fluorouracil has been researched along with Muscle Cramp in 3 studies
Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.
Muscle Cramp: A sustained and usually painful contraction of muscle fibers. This may occur as an isolated phenomenon or as a manifestation of an underlying disease process (e.g., UREMIA; HYPOTHYROIDISM; MOTOR NEURON DISEASE; etc.). (From Adams et al., Principles of Neurology, 6th ed, p1398)
Excerpt | Relevance | Reference |
---|---|---|
"There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy, including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale." | 2.79 | Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). ( Atherton, P; Dakhil, SR; Fehrenbacher, L; Flynn, KA; Grothey, A; Lewis, GC; Loprinzi, CL; Qamar, R; Qin, R; Seisler, D, 2014) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 3 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Basset-Seguin, N | 1 |
Loprinzi, CL | 1 |
Qin, R | 1 |
Dakhil, SR | 1 |
Fehrenbacher, L | 1 |
Flynn, KA | 1 |
Atherton, P | 1 |
Seisler, D | 1 |
Qamar, R | 1 |
Lewis, GC | 1 |
Grothey, A | 1 |
Uña, E | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity[NCT01099449] | Phase 3 | 362 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 Months
Intervention | AUC QLQ-CIPN20 Motor Neuropathy Score (Mean) |
---|---|
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 94.1 |
Placebo (Pre and Post) | 93.3 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 91.6 |
The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months
Intervention | score on a scale (Mean) |
---|---|
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 89.8 |
Placebo (Pre and Post) | 86.7 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 84.5 |
A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity. (NCT01099449)
Timeframe: Up to 18 months
Intervention | Doses (Mean) |
---|---|
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 8.1 |
Placebo (Pre and Post) | 8.4 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 8.0 |
(NCT01099449)
Timeframe: Up to 18 months
Intervention | Number of reported Adverse Events (Number) |
---|---|
Arm I | 290 |
Arm II | 259 |
Arm III | 296 |
(NCT01099449)
Timeframe: Up to 18 months
Intervention | percentage of patients (Number) |
---|---|
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 34.7 |
Placebo (Pre and Post) | 27.7 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 30.5 |
The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months
Intervention | score on a scale (Mean) |
---|---|
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 89.2 |
Placebo (Pre and Post) | 88.3 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 87.1 |
This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months
Intervention | score on a scale (Mean) | ||||||
---|---|---|---|---|---|---|---|
Diarrhea | Constipation | Stomach Cramping | Bowel Problems | Swallowing | Numbness in finger and toes | Tingling in finger and toes | |
Arm I | 86.7 | 90.1 | 92.8 | 89.1 | 91.2 | 83.4 | 78.9 |
Arm II | 86.2 | 88.8 | 90.6 | 88.5 | 87.6 | 81.8 | 76.5 |
Arm III | 84.5 | 88.0 | 89.4 | 84.6 | 86.7 | 80.0 | 76.3 |
Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. (NCT01099449)
Timeframe: Up to 18 months
Intervention | percentage of patients (Number) | |
---|---|---|
grade 2+ | grade 3+ | |
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 42.7 | 7.7 |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 46.1 | 7.8 |
Placebo (Pre and Post) | 44.8 | 7.8 |
This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be. (NCT01099449)
Timeframe: Up to 18 months
Intervention | percentage of patients (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Cycle 9 | Cycle 10 | Cycle 11 | Cycle 12 | |
Arm I | 10 | 24 | 32 | 34 | 34 | 31 | 35 | 32 | 34 | 29 | 28 | 27 |
Arm II | 13 | 27 | 33 | 37 | 33 | 37 | 34 | 34 | 37 | 39 | 39 | 45 |
Arm III | 14 | 28 | 32 | 36 | 39 | 33 | 34 | 33 | 32 | 30 | 33 | 32 |
Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. (NCT01099449)
Timeframe: Up to 18 months
Intervention | Days (Median) | |
---|---|---|
Time to Grade 2 Neuropathy | Time to Grade 3 Neuropathy | |
Calcium Gluconate + Magnesium Sulfate (Pre and Post) | 171 | NA |
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post) | 171 | NA |
Placebo (Pre and Post) | 173 | 208 |
1 review available for fluorouracil and Muscle Cramp
Article | Year |
---|---|
Topics: Alopecia; Anilides; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Basal Cel | 2018 |
1 trial available for fluorouracil and Muscle Cramp
Article | Year |
---|---|
Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).
Topics: Administration, Intravenous; Aged; Antineoplastic Combined Chemotherapy Protocols; Calcium; Cold Tem | 2014 |
1 other study available for fluorouracil and Muscle Cramp
Article | Year |
---|---|
Atypical presentation of acute neurotoxicity secondary to oxaliplatin.
Topics: Adenocarcinoma; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; | 2010 |