niacinamide and Central Hypothyroidism
niacinamide has been researched along with Central Hypothyroidism in 27 studies
nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.
Research Excerpts
Excerpt | Relevance | Reference |
---|---|---|
"We measured serum thyroxine (T4), free T4, 3,5,3-triiodothyronine (T3), free T3, reverse T3 (rT3), and TSH concentrations at baseline and after 26 wk in 21 patients with progressive nonmedullary thyroid carcinoma treated with sorafenib." | 9.14 | Sorafenib-induced hypothyroidism is associated with increased type 3 deiodination. ( Abdulrahman, RM; Corssmit, EP; Gelderblom, H; Hoftijzer, H; Hovens, GC; Kapiteijn, E; Pereira, AM; Reiners, C; Romijn, JA; Smit, JW; Verburg, E; Verloop, H; Visser, TJ, 2010) |
"Thyroid dysfunction and hypertension (HTN) have been sporadically reported with sunitinib (SUN) and sorafenib (SOR)." | 7.85 | Pharmacoepidemiology of Clinically Relevant Hypothyroidism and Hypertension from Sunitinib and Sorafenib. ( Aubert, RE; Clore, G; Epstein, RS; Herrera, V; Kourlas, H; La-Beck, NM; McLeod, HL; Walko, CM, 2017) |
" Subclinical hypothyroidism was characterized by serum TSH above the upper limit of normal and both total triiodothyronine (T3) and thyroxine (T4) within normal limits." | 7.77 | Hypothyroidism correlates with a better prognosis in metastatic renal cancer patients treated with sorafenib or sunitinib. ( Bierer, S; Herrmann, E; Hertle, L; Hoffmeister, I; Köpke, T; Papavassilis, P; Riesenbeck, LM; Thielen, B, 2011) |
"Tyrosine kinase inhibitors (TKIs) provide more effective targeted treatments for cancer, but are subject to a variety of adverse effects, such as hypothyroidism." | 5.43 | Hypothyroidism Side Effect in Patients Treated with Sunitinib or Sorafenib: Clinical and Structural Analyses. ( Lin, Z; Shu, M; Wang, R; Zai, X; Zhang, B, 2016) |
"Twenty-one patients (sorafenib 9, sunitinib 12) developed "hypothyroidism" 95±88 days (range 12-315 days) after the start of treatment." | 5.16 | Thyroid size change by CT monitoring after sorafenib or sunitinib treatment in patients with renal cell carcinoma: comparison with thyroid function. ( Fujii, M; Fujisawa, M; Kitajima, K; Maeda, T; Miyake, H; Ohno, Y; Sugimura, K; Takahashi, S; Yoshikawa, T, 2012) |
"We measured serum thyroxine (T4), free T4, 3,5,3-triiodothyronine (T3), free T3, reverse T3 (rT3), and TSH concentrations at baseline and after 26 wk in 21 patients with progressive nonmedullary thyroid carcinoma treated with sorafenib." | 5.14 | Sorafenib-induced hypothyroidism is associated with increased type 3 deiodination. ( Abdulrahman, RM; Corssmit, EP; Gelderblom, H; Hoftijzer, H; Hovens, GC; Kapiteijn, E; Pereira, AM; Reiners, C; Romijn, JA; Smit, JW; Verburg, E; Verloop, H; Visser, TJ, 2010) |
" Sunitinib and sorafenib are multitargeted TKIs that have been demonstrated to induce hypothyroidism and thyroid dysfunction." | 4.85 | Hypothyroidism related to tyrosine kinase inhibitors: an emerging toxic effect of targeted therapy. ( Barnabei, A; Corsello, SM; Gasparini, G; Longo, R; Torino, F, 2009) |
"Thyroid dysfunction and hypertension (HTN) have been sporadically reported with sunitinib (SUN) and sorafenib (SOR)." | 3.85 | Pharmacoepidemiology of Clinically Relevant Hypothyroidism and Hypertension from Sunitinib and Sorafenib. ( Aubert, RE; Clore, G; Epstein, RS; Herrera, V; Kourlas, H; La-Beck, NM; McLeod, HL; Walko, CM, 2017) |
"Sunitinib and sorafenib can induce serious adverse drug reactions (ADR) such as hypothyroidism." | 3.78 | Incidence of thyroid hormone therapy in patients treated with sunitinib or sorafenib: a cohort study. ( Czeche, S; Feldt, S; Franzmann, A; Ludwig, WD; Quinzler, R; Schulz, M; Schüssel, K, 2012) |
"Sunitinib and sorafenib are tyrosine kinase inhibitors used in metastatic renal cell carcinoma and are known to cause hypothyroidism in a subset of patients." | 3.78 | Thyroid dysfunction in patients treated with sunitinib or sorafenib. ( Breaker, K; Clemons, J; Flaig, TW; Gao, D; Garfield, D; Naam, M, 2012) |
" Subclinical hypothyroidism was characterized by serum TSH above the upper limit of normal and both total triiodothyronine (T3) and thyroxine (T4) within normal limits." | 3.77 | Hypothyroidism correlates with a better prognosis in metastatic renal cancer patients treated with sorafenib or sunitinib. ( Bierer, S; Herrmann, E; Hertle, L; Hoffmeister, I; Köpke, T; Papavassilis, P; Riesenbeck, LM; Thielen, B, 2011) |
"Eight patients (21%) had thyroid dysfunction possibly caused by sorafenib [seven hypothyroidism (18%) and one hyperthyroidism (3%)] and eight additional patients (21%) had findings compatible with nonthyroidal illness." | 3.74 | Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib. ( Bukowski, R; Dreicer, R; Elson, P; Garcia, J; Ioachimescu, AG; Mekhail, T; Rini, BI; Tamaskar, I; Wood, L, 2008) |
"Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3." | 2.78 | Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. ( Akaza, H; Chen, C; Kanayama, H; Kim, S; Naito, S; Ozono, S; Shinohara, N; Tarazi, J; Tomita, Y; Tsukamoto, T; Ueda, T; Uemura, H, 2013) |
"Fatigue und hypothyroidism are two common side effects of TKI therapy that can often appear simultaneously." | 2.53 | [Side effect management of tyrosine kinase inhibitors in urology : Fatigue and hypothyroidism]. ( Keck, B; Lieb, V; Lüdecke, G; Sikic, D, 2016) |
" This has raised challenges in the management of adverse events (AEs) associated with the six targeted agents approved in RCC-sorafenib, sunitinib, pazopanib, bevacizumab (in combination with interferon alpha), temsirolimus, and everolimus." | 2.48 | Targeted therapies for renal cell carcinoma: review of adverse event management strategies. ( Eisen, T; Escudier, B; Izzedine, H; Mulders, P; Pyle, L; Robert, C; Sternberg, CN; Zbinden, S, 2012) |
"Tyrosine kinase inhibitors (TKIs) provide more effective targeted treatments for cancer, but are subject to a variety of adverse effects, such as hypothyroidism." | 1.43 | Hypothyroidism Side Effect in Patients Treated with Sunitinib or Sorafenib: Clinical and Structural Analyses. ( Lin, Z; Shu, M; Wang, R; Zai, X; Zhang, B, 2016) |
" Clinicians have changed their practice and are faced with a number of new adverse events." | 1.36 | [Management of side effects associated with antiangiogenic treatment in renal cell carcinoma]. ( Boyle, H; Fléchon, A; Négrier, S, 2010) |
Research
Studies (27)
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 3 (11.11) | 18.7374 |
1990's | 2 (7.41) | 18.2507 |
2000's | 5 (18.52) | 29.6817 |
2010's | 17 (62.96) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors
Authors | Studies |
---|---|
Ueda, T | 1 |
Uemura, H | 1 |
Tomita, Y | 1 |
Tsukamoto, T | 1 |
Kanayama, H | 1 |
Shinohara, N | 1 |
Tarazi, J | 1 |
Chen, C | 1 |
Kim, S | 1 |
Ozono, S | 1 |
Naito, S | 1 |
Akaza, H | 1 |
Shu, M | 1 |
Zai, X | 1 |
Zhang, B | 1 |
Wang, R | 1 |
Lin, Z | 1 |
Sikic, D | 1 |
Lüdecke, G | 1 |
Lieb, V | 1 |
Keck, B | 1 |
Walko, CM | 1 |
Aubert, RE | 1 |
La-Beck, NM | 1 |
Clore, G | 1 |
Herrera, V | 1 |
Kourlas, H | 1 |
Epstein, RS | 1 |
McLeod, HL | 1 |
Marquez, CB | 1 |
Smithberger, EE | 1 |
Bair, SM | 1 |
Wenham, RM | 1 |
Fenske, NA | 1 |
Glass, LF | 1 |
Cherpelis, BS | 1 |
Torino, F | 2 |
Corsello, SM | 2 |
Longo, R | 2 |
Barnabei, A | 2 |
Gasparini, G | 2 |
La Vine, DB | 1 |
Coleman, TA | 1 |
Davis, CH | 1 |
Carbonell, CE | 1 |
Davis, WB | 1 |
Fléchon, A | 1 |
Boyle, H | 1 |
Négrier, S | 1 |
Abdulrahman, RM | 1 |
Verloop, H | 1 |
Hoftijzer, H | 1 |
Verburg, E | 1 |
Hovens, GC | 1 |
Corssmit, EP | 1 |
Reiners, C | 1 |
Gelderblom, H | 1 |
Pereira, AM | 1 |
Kapiteijn, E | 1 |
Romijn, JA | 1 |
Visser, TJ | 1 |
Smit, JW | 1 |
Schmidinger, M | 1 |
Vogl, UM | 1 |
Bojic, M | 1 |
Lamm, W | 1 |
Heinzl, H | 1 |
Haitel, A | 1 |
Clodi, M | 1 |
Kramer, G | 1 |
Zielinski, CC | 1 |
Rini, B | 1 |
Riesenbeck, LM | 1 |
Bierer, S | 1 |
Hoffmeister, I | 1 |
Köpke, T | 1 |
Papavassilis, P | 1 |
Hertle, L | 1 |
Thielen, B | 1 |
Herrmann, E | 1 |
Pérez López, G | 1 |
Carrasco De La Fuente, M | 1 |
Menacho Román, M | 1 |
González Albarrán, O | 1 |
Cano Megías, M | 1 |
Block, MS | 1 |
Kohli, M | 1 |
Rini, BI | 2 |
Kitajima, K | 1 |
Takahashi, S | 1 |
Maeda, T | 1 |
Yoshikawa, T | 1 |
Ohno, Y | 1 |
Fujii, M | 1 |
Miyake, H | 1 |
Fujisawa, M | 1 |
Sugimura, K | 1 |
Eisen, T | 1 |
Sternberg, CN | 1 |
Robert, C | 1 |
Mulders, P | 1 |
Pyle, L | 1 |
Zbinden, S | 1 |
Izzedine, H | 1 |
Escudier, B | 1 |
Feldt, S | 1 |
Schüssel, K | 1 |
Quinzler, R | 1 |
Franzmann, A | 1 |
Czeche, S | 1 |
Ludwig, WD | 1 |
Schulz, M | 1 |
Clemons, J | 1 |
Gao, D | 1 |
Naam, M | 1 |
Breaker, K | 1 |
Garfield, D | 1 |
Flaig, TW | 1 |
BETTLEY, FR | 1 |
Robinson, SI | 1 |
Hobday, TJ | 1 |
Sathananthan, A | 1 |
Morris, JC | 1 |
McWilliams, RR | 1 |
Tamaskar, I | 1 |
Bukowski, R | 1 |
Elson, P | 1 |
Ioachimescu, AG | 1 |
Wood, L | 1 |
Dreicer, R | 1 |
Mekhail, T | 1 |
Garcia, J | 1 |
Mowbray, J | 3 |
Hardy, DL | 2 |
Thomas, WE | 1 |
Wren, JC | 1 |
Clinical Trials (2)
Trial Overview
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL[NCT00678392] | Phase 3 | 723 participants (Actual) | Interventional | 2008-09-03 | Completed | ||
Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma[NCT00887107] | Phase 2 | 32 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Duration of Response (DR)
DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Months (Median) |
---|---|
Axitinib 5 mg | 11.0 |
Sorafenib 400 mg | 10.6 |
Objective Response Rate (ORR)
ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Percentage of participants (Number) |
---|---|
Axitinib 5 mg | 19.4 |
Sorafenib 400 mg | 9.4 |
Overall Survival (OS)
OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Months (Median) |
---|---|
Axitinib 5 mg | 20.1 |
Sorafenib 400 mg | 19.2 |
Progression-Free Survival (PFS)
PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Months (Median) |
---|---|
Axitinib 5 mg | 6.7 |
Sorafenib 400 mg | 4.7 |
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (n =347, 341) | Cycle 2/Day1 (n =326, 307) | Cycle 3/Day1 (n =287, 248) | Cycle 4/Day1 (n =262, 226) | Cycle 5/Day1 (n =244, 207) | Cycle 6/Day1 (n =221, 178) | Cycle 7/Day1 (n =213, 163) | Cycle 8/Day1 (n =181, 136) | Cycle 9/Day1 (n =169, 120) | Cycle 10/Day1 (n =151, 98) | Cycle 11/Day1 (n =126, 87) | Cycle 12/Day1 (n =110, 73) | Cycle 13/Day1 (n =96, 61) | Cycle 14/Day1 (n =80, 57) | Cycle 15/Day1 (n =63, 41) | Cycle 16/Day1 (n =54, 37) | Cycle 17/Day1 (n =48, 29) | Cycle 18/Day1 (n =37, 20) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =21, 12) | Cycle 21/Day1 (n =16, 7) | End of Treatment (n =169, 196) | Follow up (n =76, 106) | |
Axitinib 5 mg | 0.732 | 0.716 | 0.722 | 0.730 | 0.730 | 0.734 | 0.718 | 0.756 | 0.760 | 0.734 | 0.764 | 0.744 | 0.760 | 0.723 | 0.730 | 0.749 | 0.779 | 0.755 | 0.734 | 0.794 | 0.700 | 0.608 | 0.682 |
Sorafenib 400 mg | 0.731 | 0.696 | 0.709 | 0.716 | 0.711 | 0.704 | 0.728 | 0.702 | 0.730 | 0.730 | 0.724 | 0.734 | 0.753 | 0.752 | 0.758 | 0.785 | 0.764 | 0.755 | 0.804 | 0.771 | 0.771 | 0.612 | 0.666 |
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (n =341, 339) | Cycle 2/Day1 (n =317, 302) | Cycle 3/Day1 (n =280, 250) | Cycle 4/Day1 (n =261, 224) | Cycle 5/Day1 (n =244, 205) | Cycle 6/Day1 (n =220, 178) | Cycle 7/Day1 (n =209, 163) | Cycle 8/Day1 (n =180, 139) | Cycle 9/Day1 (n =168, 121) | Cycle 10/Day1 (n =151, 98) | Cycle 11/Day1 (n =126, 87) | Cycle 12/Day1 (n =111, 73) | Cycle 13/Day1 (n =94, 61) | Cycle 14/Day1 (n =81, 58) | Cycle 15/Day1 (n =62, 42) | Cycle 16/Day1 (n =52, 37) | Cycle 17/Day1 (n =48, 30) | Cycle 18/Day1 (n =37, 23) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =21, 12) | Cycle 21/Day1 (n =16, 7) | End of Treatment (n =166, 197) | Follow up (n =76, 109) | |
Axitinib 5 mg | 70.560 | 69.003 | 69.843 | 69.180 | 69.705 | 69.900 | 69.919 | 70.756 | 70.667 | 70.629 | 72.103 | 71.730 | 70.723 | 69.420 | 73.016 | 70.269 | 71.375 | 70.459 | 71.034 | 73.143 | 74.563 | 61.759 | 64.382 |
Sorafenib 400 mg | 70.351 | 67.606 | 69.712 | 70.759 | 71.888 | 71.365 | 72.282 | 71.475 | 73.380 | 75.102 | 74.586 | 73.959 | 75.693 | 75.362 | 75.357 | 73.676 | 73.767 | 73.870 | 70.571 | 66.917 | 64.714 | 61.690 | 66.037 |
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (n =346, 342) | Cycle 2/Day1 (n =319, 296) | Cycle 3/Day1 (n =279, 246) | Cycle 4/Day1 (n =257, 221) | Cycle 5/Day1 (n =238, 203) | Cycle 6/Day1 (n =213, 179) | Cycle 7/Day1 (n =206, 158) | Cycle 8/Day1 (n =177, 136) | Cycle 9/Day1 (n =163, 118) | Cycle 10/Day1 (n =146, 96) | Cycle 11/Day1 (n =122, 85) | Cycle 12/Day1 (n =110, 70) | Cycle 13/Day1 (n =92, 58) | Cycle 14/Day1 (n =81, 54) | Cycle 15/Day1 (n =61, 38) | Cycle 16/Day1 (n =52, 34) | Cycle 17/Day1 (n =47, 28) | Cycle 18/Day1 (n =36, 22) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =20, 12) | Cycle 21/Day1 (n =15, 7) | End of treatment (n=163, 191) | Follow up (n =80, 110) | |
Axitinib 5 mg | 43.199 | 42.351 | 42.590 | 42.791 | 42.968 | 42.949 | 42.747 | 43.580 | 43.191 | 43.312 | 44.119 | 44.517 | 44.492 | 44.485 | 45.291 | 45.217 | 45.242 | 44.861 | 45.379 | 47.050 | 45.850 | 38.328 | 41.919 |
Sorafenib 400 mg | 43.339 | 41.668 | 42.424 | 43.424 | 42.907 | 43.057 | 43.578 | 44.074 | 44.518 | 44.771 | 44.438 | 44.357 | 45.261 | 44.898 | 45.053 | 44.445 | 44.438 | 44.182 | 45.026 | 44.780 | 44.494 | 38.457 | 40.028 |
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms. (NCT00678392)
Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Intervention | Units on a scale (Mean) | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (n =346, 341) | Cycle 2/Day1 (n =319, 295) | Cycle 3/Day1 (n =279, 244) | Cycle 4/Day1 (n =257, 220) | Cycle 5/Day1 (n =238, 202) | Cycle 6/Day1 (n =213, 178) | Cycle 7/Day1 (n =206, 157) | Cycle 8/Day1 (n =177, 135) | Cycle 9/Day1 (n =163, 117) | Cycle 10/Day1 (n =146, 96) | Cycle 11/Day1 (n =122, 85) | Cycle 12/Day1 (n =110, 70) | Cycle 13/Day1 (n =92, 58) | Cycle 14/Day1 (n =81, 54) | Cycle 15/Day1 (n =61, 38) | Cycle 16/Day1 (n =52, 34) | Cycle 17/Day1 (n =47, 28) | Cycle 18/Day1 (n =36, 22) | Cycle 19/Day1 (n =29, 14) | Cycle 20/Day1 (n =20, 12) | Cycle 21/Day1 (n =15, 7) | End of Treatment (n =163, 191) | Follow up (n =80, 110) | |
Axitinib 5 mg | 28.874 | 28.211 | 28.640 | 28.822 | 28.869 | 29.159 | 29.042 | 29.520 | 29.194 | 29.343 | 29.762 | 29.764 | 29.594 | 29.711 | 30.324 | 30.430 | 30.551 | 30.194 | 30.130 | 31.300 | 31.067 | 26.288 | 28.263 |
Sorafenib 400 mg | 28.975 | 28.399 | 28.640 | 29.130 | 29.007 | 29.098 | 29.361 | 29.619 | 29.884 | 29.604 | 29.366 | 29.257 | 29.666 | 29.820 | 29.500 | 29.474 | 28.737 | 29.045 | 29.286 | 29.250 | 30.143 | 26.517 | 27.516 |
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alanine aminotransferase: Grade 1 (n =331, 313) | Alanine aminotransferase: Grade 2 (n =331, 313) | Alanine aminotransferase: Grade 3 (n =331, 313) | Alanine aminotransferase: Grade 4 (n =331, 313) | Alkaline phosphatase: Grade 1 (n =336, 319) | Alkaline phosphatase: Grade 2 (n =336, 319) | Alkaline phosphatase: Grade 3 (n =336, 319) | Alkaline phosphatase: Grade 4 (n =336, 319) | Amylase: Grade 1 (n =338, 319) | Amylase: Grade 2 (n =338, 319) | Amylase: Grade 3 (n =338, 319) | Amylase: Grade 4 (n =338, 319) | Aspartate aminotransferase: Grade 1 (n =331, 311) | Aspartate aminotransferase: Grade 2 (n =331, 311) | Aspartate aminotransferase: Grade 3 (n =331, 311) | Aspartate aminotransferase: Grade 4 (n =331, 311) | Bicarbonate: Grade 1 (n =314, 291) | Bicarbonate: Grade 2 (n =314, 291) | Bicarbonate: Grade 3 (n =314, 291) | Bicarbonate: Grade 4 (n =314, 291) | Bilirubin: Grade 1 (n =336, 318) | Bilirubin: Grade 2 (n =336, 318) | Bilirubin: Grade 3 (n =336, 318) | Bilirubin: Grade 4 (n =336, 318) | Creatinine: Grade 1 (n =336, 318) | Creatinine: Grade 2 (n =336, 318) | Creatinine: Grade 3 (n =336, 318) | Creatinine: Grade 4 (n =336, 318) | Hypercalcemia: Grade 1 (n =336, 319) | Hypercalcemia: Grade 2 (n =336, 319) | Hypercalcemia: Grade 3 (n =336, 319) | Hypercalcemia: Grade 4 (n =336, 319) | Hyperglycemia: Grade 1 (n =336, 319) | Hyperglycemia: Grade 2 (n =336, 319) | Hyperglycemia: Grade 3 (n =336, 319) | Hyperglycemia: Grade 4 (n =336, 319) | Hyperkalemia: Grade 1 (n =333, 314) | Hyperkalemia: Grade 2 (n =333, 314) | Hyperkalemia: Grade 3 (n =333, 314) | Hyperkalemia: Grade 4 (n =333, 314) | Hypernatremia: Grade 1 (n =338, 319) | Hypernatremia: Grade 2 (n =338, 319) | Hypernatremia: Grade 3 (n =338, 319) | Hypernatremia: Grade 4 (n =338, 319) | Hypoalbuminemia: Grade 1 (n =337, 319) | Hypoalbuminemia: Grade 2 (n =337, 319) | Hypoalbuminemia: Grade 3 (n =337, 319) | Hypoalbuminemia: Grade 4 (n =337, 319) | Hypocalcemia: Grade 1 (n =336, 319) | Hypocalcemia: Grade 2 (n =336, 319) | Hypocalcemia: Grade 3 (n =336, 319) | Hypocalcemia: Grade 4 (n =336, 319) | Hypoglycemia: Grade 1 (n =336, 319) | Hypoglycemia: Grade 2 (n =336, 319) | Hypoglycemia: Grade 3 (n =336, 319) | Hypoglycemia: Grade 4 (n =336, 319) | Hypokalemia: Grade 1 (n =333, 314) | Hypokalemia: Grade 2 (n =333, 314) | Hypokalemia: Grade 3 (n =333, 314) | Hypokalemia: Grade 4 (n =333, 314) | Hyponatremia: Grade 1 (n =338, 319) | Hyponatremia: Grade 2 (n =338, 319) | Hyponatremia: Grade 3 (n =338, 319) | Hyponatremia: Grade 4 (n =338, 319) | Hypophosphatemia: Grade 1 (n =336, 318) | Hypophosphatemia: Grade 2 (n =336, 318) | Hypophosphatemia: Grade 3 (n =336, 318) | Hypophosphatemia: Grade 4 (n =336, 318) | Lipase: Grade 1 (n =338, 319) | Lipase: Grade 2 (n =338, 319) | Lipase: Grade 3 (n =338, 319) | Lipase: Grade 4 (n =338, 319) | |
Axitinib 5 mg | 65 | 8 | 1 | 0 | 88 | 8 | 4 | 0 | 64 | 12 | 7 | 0 | 59 | 5 | 1 | 0 | 127 | 11 | 0 | 1 | 16 | 8 | 1 | 0 | 155 | 30 | 0 | 0 | 92 | 8 | 1 | 0 | 41 | 45 | 7 | 0 | 0 | 42 | 9 | 0 | 34 | 19 | 3 | 0 | 37 | 11 | 1 | 0 | 25 | 4 | 2 | 1 | 23 | 12 | 1 | 0 | 22 | 0 | 0 | 0 | 33 | 0 | 11 | 1 | 4 | 33 | 6 | 0 | 53 | 22 | 14 | 2 |
Sorafenib 400 mg | 57 | 6 | 2 | 3 | 92 | 15 | 3 | 0 | 76 | 21 | 6 | 1 | 67 | 7 | 4 | 0 | 115 | 10 | 0 | 0 | 12 | 2 | 1 | 0 | 121 | 9 | 1 | 0 | 22 | 1 | 0 | 0 | 28 | 37 | 7 | 0 | 0 | 22 | 8 | 0 | 23 | 14 | 1 | 2 | 25 | 31 | 2 | 0 | 67 | 18 | 2 | 2 | 9 | 16 | 1 | 0 | 21 | 0 | 5 | 0 | 27 | 0 | 6 | 1 | 8 | 99 | 51 | 0 | 76 | 25 | 40 | 7 |
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hemoglobin: Grade 1 (n =320, 316) | Hemoglobin: Grade 2 (n =320, 316) | Hemoglobin: Grade 3 (n =320, 316) | Hemoglobin: Grade 4 (n =320, 316) | Lymphocytes: Grade 1 (n =317, 309) | Lymphocytes: Grade 2 (n =317, 309) | Lymphocytes: Grade 3 (n =317, 309) | Lymphocytes: Grade 4 (n =317, 309) | Neutrophils: Grade 1 (n =316, 308) | Neutrophils: Grade 2 (n =316, 308) | Neutrophils: Grade 3 (n =316, 308) | Neutrophils: Grade 4 (n =316, 308) | Platelets: Grade 1 (n =312, 310) | Platelets: Grade 2 (n =312, 310) | Platelets: Grade 3 (n =312, 310) | Platelets: Grade 4 (n =312, 310) | White Blood Cells: Grade 1 (n =320, 315) | White Blood Cells: Grade 2 (n =320, 315) | White Blood Cells: Grade 3 (n =320, 315) | White Blood Cells: Grade 4 (n =320, 315) | |
Axitinib 5 mg | 93 | 19 | 1 | 0 | 7 | 89 | 10 | 0 | 13 | 4 | 2 | 0 | 47 | 0 | 1 | 0 | 32 | 4 | 0 | 0 |
Sorafenib 400 mg | 112 | 41 | 11 | 1 | 7 | 93 | 11 | 0 | 20 | 4 | 2 | 0 | 41 | 3 | 0 | 0 | 36 | 12 | 1 | 0 |
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Urine blood/ hemoglobin: Grade 1 (n =304, 272) | Urine blood/ hemoglobin: Grade 2 (n =304, 272) | Urine blood/ hemoglobin: Grade 3 (n =304, 272) | Urine blood/ hemoglobin: Grade 4 (n =304, 272) | Urine glucose: Grade 1 (n =322, 286) | Urine glucose: Grade 2 (n =322, 286) | Urine glucose: Grade 3 (n =322, 286) | Urine glucose: Grade 4 (n =322, 286) | Urine protein: Grade 1 (n =326, 289) | Urine protein: Grade 2 (n =326, 289) | Urine protein: Grade 3 (n =326, 289) | Urine protein: Grade 4 (n =326, 289) | |
Axitinib 5 mg | 45 | 1 | 0 | 0 | 12 | 0 | 0 | 1 | 105 | 31 | 27 | 9 |
Sorafenib 400 mg | 35 | 0 | 0 | 0 | 13 | 3 | 0 | 1 | 91 | 27 | 21 | 7 |
Percentage of Participants With Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Percentage of participants (Number) | ||||
---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
Axitinib 5 mg | 3.9 | 20.1 | 47.6 | 10.6 | 13.9 |
Sorafenib 400 mg | 3.1 | 21.7 | 52.4 | 11.5 | 9.3 |
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Percentage of participants (Number) | |
---|---|---|
AEs | SAEs | |
Axitinib 5 mg | 96.1 | 40.7 |
Sorafenib 400 mg | 98.0 | 35.8 |
Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs. (NCT00678392)
Timeframe: From initiation of treatment up to follow-up period (up to 3 years)
Intervention | Percentage of participants (Number) | |
---|---|---|
AEs | SAEs | |
Axitinib 5 mg | 92.2 | 15.3 |
Sorafenib 400 mg | 95.2 | 13.8 |
Reviews
4 reviews available for niacinamide and Central Hypothyroidism
Article | Year |
---|---|
[Side effect management of tyrosine kinase inhibitors in urology : Fatigue and hypothyroidism].
Topics: Anilides; Antineoplastic Agents; Axitinib; Carcinoma, Renal Cell; Disease Progression; Enzyme Inhibi | 2016 |
Hypothyroidism related to tyrosine kinase inhibitors: an emerging toxic effect of targeted therapy.
Topics: Antineoplastic Agents; Benzenesulfonates; Drug Therapy, Combination; Humans; Hypothyroidism; Indoles | 2009 |
Review: thyroid function abnormalities in patients receiving VEGF-targeted therapy.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Hypothyroidism; Molecular T | 2011 |
Targeted therapies for renal cell carcinoma: review of adverse event management strategies.
Topics: Anorexia; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Combined Chemothe | 2012 |
Trials
3 trials available for niacinamide and Central Hypothyroidism
Article | Year |
---|---|
Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial.
Topics: Adult; Aged; Aged, 80 and over; Asian People; Axitinib; Carcinoma, Renal Cell; Diarrhea; Disease-Fre | 2013 |
Sorafenib-induced hypothyroidism is associated with increased type 3 deiodination.
Topics: Aged; Aged, 80 and over; Benzenesulfonates; Carcinoma; Female; Humans; Hypothyroidism; Male; Middle | 2010 |
Thyroid size change by CT monitoring after sorafenib or sunitinib treatment in patients with renal cell carcinoma: comparison with thyroid function.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Fem | 2012 |
Other Studies
20 other studies available for niacinamide and Central Hypothyroidism
Article | Year |
---|---|
Hypothyroidism Side Effect in Patients Treated with Sunitinib or Sorafenib: Clinical and Structural Analyses.
Topics: Carcinoma, Renal Cell; Female; Humans; Hypothyroidism; Indoles; Kidney Neoplasms; Male; Models, Mole | 2016 |
Pharmacoepidemiology of Clinically Relevant Hypothyroidism and Hypertension from Sunitinib and Sorafenib.
Topics: Cohort Studies; Female; Humans; Hypertension; Hypothyroidism; Indoles; Male; Middle Aged; Niacinamid | 2017 |
Multiple keratoacanthomas arising in the setting of sorafenib therapy: novel chemoprophylaxis with bexarotene.
Topics: Adenocarcinoma, Papillary; Anticarcinogenic Agents; Antineoplastic Agents; Antineoplastic Combined C | 2009 |
Is hypothyroidism a clinically relevant toxicity of tyrosine kinase inhibitors?
Topics: Antineoplastic Agents; Benzenesulfonates; Humans; Hypothyroidism; Indoles; Niacinamide; Phenylurea C | 2009 |
Frequent dose interruptions are required for patients receiving oral kinase inhibitor therapy for advanced renal cell carcinoma.
Topics: Administration, Oral; Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Agents; Benzenesulfonates | 2010 |
[Management of side effects associated with antiangiogenic treatment in renal cell carcinoma].
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Benzenesulfonate | 2010 |
Hypothyroidism in patients with renal cell carcinoma: blessing or curse?
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Dis | 2011 |
Kidney cancer: Does hypothyroidism predict clinical outcome?
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Hypothyroidism; Indoles; Ki | 2011 |
Hypothyroidism correlates with a better prognosis in metastatic renal cancer patients treated with sorafenib or sunitinib.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Fem | 2011 |
[Management of hypothyroidism secondary to tyrosine kinase inhibitors: description of treatment in three distinct clinical settings].
Topics: Adult; Benzamides; Benzenesulfonates; Carcinoma, Renal Cell; Choristoma; Female; Gastrointestinal St | 2011 |
Clinical hypothyroidism in a renal cell carcinoma patient treated with sorafenib.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Humans; Hypothyroidism; Lung Neopla | 2011 |
Incidence of thyroid hormone therapy in patients treated with sunitinib or sorafenib: a cohort study.
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Renal Cell; Cohort Studies; Databases as Topic; | 2012 |
Thyroid dysfunction in patients treated with sunitinib or sorafenib.
Topics: Aged; Antineoplastic Agents; Carcinoma, Renal Cell; Disease-Free Survival; Female; Humans; Hypothyro | 2012 |
CHILBLAIN LUPUS ERYTHEMATOSUS.
Topics: Chilblains; Chloroquine; Fluocinolone Acetonide; Frostbite; Humans; Hydroxychloroquine; Hypothyroidi | 1964 |
Can sorafenib cause hypothyroidism?
Topics: Antineoplastic Agents; Benzenesulfonates; Carcinoma, Islet Cell; Female; Humans; Hypothyroidism; Liv | 2007 |
Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Benzenesulfonates; Carcinoma, Renal Cell; Chem | 2008 |
Direct thyroid hormone signalling via ADP-ribosylation controls mitochondrial nucleotide transport and membrane leakiness by changing the conformation of the adenine nucleotide transporter.
Topics: Adenine Nucleotides; Adenosine Diphosphate Ribose; Allosteric Regulation; Animals; Calcium; Electrop | 1996 |
The rapid response of isolated mitochondrial particles to 0.1 nM-tri-iodothyronine correlates with the ADP-ribosylation of a single inner-membrane protein.
Topics: Adenosine Diphosphate; Adenosine Diphosphate Ribose; Animals; Chemical Precipitation; Electrophoresi | 1992 |
Evidence for ADP-ribosylation in the mechanism of rapid thyroid hormone control of mitochondria.
Topics: Adenosine Diphosphate Ribose; Animals; Hypothyroidism; Intracellular Membranes; Male; Membrane Prote | 1987 |
Thyroid function and coronary atherosclerosis.
Topics: Adult; Aged; Arteriosclerosis; Ascorbic Acid; Calcium; Cholesterol; Coronary Disease; Electrocardiog | 1968 |