Page last updated: 2024-10-30

loperamide and Colorectal Neoplasms

loperamide has been researched along with Colorectal Neoplasms in 8 studies

Loperamide: One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
loperamide : A synthetic piperidine derivative, effective against diarrhoea resulting from gastroenteritis or inflammatory bowel disease.

Colorectal Neoplasms: Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Research Excerpts

ExcerptRelevanceReference
"Thirty-seven colorectal cancer patients with grade 1-4 diarrhea (NCICTC) caused by chemotherapy with 5-FU-containing regimens, received oral loperamide at the initial dose of 4 mg followed by 4 mg every 8 h (total dose 16 mg/24 h)."9.09High-dose loperamide in the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients. ( Agostinelli, R; Amadori, D; Bichisao, E; Cascinu, S; Catalano, G; Catalano, V; Giordani, P; Luppi, G; Sansoni, E; Silingardi, V, 2000)
" The incidence of severe diarrhea is reduced by using a starting dose of irinotecan 125 mg/m2 and by initiating loperamide at the earliest signs of diarrhea."9.08Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. ( Burris, HA; Eckardt, JR; Eckhardt, SG; Elfring, GL; Hilsenbeck, SG; Kuhn, JG; Nelson, J; Rinaldi, DA; Rodriguez, GI; Rothenberg, ML; Schaaf, LJ; Smith, LS; Thurman, AM; Von Hoff, DD; Weiss, GR, 1996)
" The first cohort of 14 consecutive patients explored for the mechanism of diarrhea received acetorphan (a new enkephalinase inhibitor) 100 mg three times daily; the second 14-patient cohort received, in addition to acetorphan, loperamide 4 mg three times daily."9.08Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment. ( Bastian, G; Bonnay, M; Cote, C; Cvitkovic, E; Hagipantelli, R; Herait, P; Mahjoubi, M; Mignard, D; Misset, JL; Saliba, F; Vassal, G, 1998)
"Eighty patients with colorectal cancer were randomized within 2 weeks after surgery to receive either modified BSS or Loperamide combined with the respective dummy."5.69Effects of Modified Baizhu Shaoyao San on Postoperative Diarrhea in Colorectal Cancer Patients: A Single-Blind, Randomized Controlled Trial. ( Fei, M; Luo, M; Wu, Y; Zhang, J; Zhang, L; Zhu, C, 2023)
"Patients with colorectal cancer starting adjuvant or first-line treatment with a chemotherapy combination containing fluorouracil, capecitabine, and/or irinotecan were randomly assigned to receive octreotide LAR 30 mg intramuscularly every 4 weeks (experimental arm) or the physician's treatment of choice in case of diarrhea (control arm)."5.19Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: the LARCID trial. ( Andrade, AC; Barrios, CH; Chinen, RN; Correa, M; Coutinho, AK; del Giglio, A; Dutra, C; Forones, NM; Hoff, PM; Passos, VQ; Portella, Mdo S; Saragiotto, DF; van Eyll, B, 2014)
"Thirty-seven colorectal cancer patients with grade 1-4 diarrhea (NCICTC) caused by chemotherapy with 5-FU-containing regimens, received oral loperamide at the initial dose of 4 mg followed by 4 mg every 8 h (total dose 16 mg/24 h)."5.09High-dose loperamide in the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients. ( Agostinelli, R; Amadori, D; Bichisao, E; Cascinu, S; Catalano, G; Catalano, V; Giordani, P; Luppi, G; Sansoni, E; Silingardi, V, 2000)
" The incidence of severe diarrhea is reduced by using a starting dose of irinotecan 125 mg/m2 and by initiating loperamide at the earliest signs of diarrhea."5.08Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. ( Burris, HA; Eckardt, JR; Eckhardt, SG; Elfring, GL; Hilsenbeck, SG; Kuhn, JG; Nelson, J; Rinaldi, DA; Rodriguez, GI; Rothenberg, ML; Schaaf, LJ; Smith, LS; Thurman, AM; Von Hoff, DD; Weiss, GR, 1996)
" The first cohort of 14 consecutive patients explored for the mechanism of diarrhea received acetorphan (a new enkephalinase inhibitor) 100 mg three times daily; the second 14-patient cohort received, in addition to acetorphan, loperamide 4 mg three times daily."5.08Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment. ( Bastian, G; Bonnay, M; Cote, C; Cvitkovic, E; Hagipantelli, R; Herait, P; Mahjoubi, M; Mignard, D; Misset, JL; Saliba, F; Vassal, G, 1998)
"A Phase I study was performed to determine the maximum tolerated dose (MTD), toxicities, and pharmacokinetic profile of irinotecan (CPT-11) and its active metabolites when given on a once-every-3-week schedule."2.69Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy. ( Adjei, AA; Alberts, SA; Burch, PA; Elfring, G; Erlichman, C; Goldberg, RM; Miller, LL; Pitot, HC; Reid, JM; Rubin, J; Schaaf, LJ; Skaff, PA; Sloan, JA, 2000)
"Irinotecan is a selective inhibitor of topoisomerase I, an enzyme part of the replication and transcription system of DNA."2.42New approaches to prevent intestinal toxicity of irinotecan-based regimens. ( Alimonti, A; Cognetti, F; Di Palma, M; Ferretti, G; Gelibter, A; Pavese, I; Rasio, D; Satta, F; Vecchione, A, 2004)

Research

Studies (8)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's2 (25.00)18.2507
2000's3 (37.50)29.6817
2010's2 (25.00)24.3611
2020's1 (12.50)2.80

Authors

AuthorsStudies
Fei, M1
Zhang, J1
Zhu, C1
Luo, M1
Zhang, L1
Wu, Y1
Major, GAD1
Gunn, D1
Hoff, PM1
Saragiotto, DF1
Barrios, CH1
del Giglio, A1
Coutinho, AK1
Andrade, AC1
Dutra, C1
Forones, NM1
Correa, M1
Portella, Mdo S1
Passos, VQ1
Chinen, RN1
van Eyll, B1
Alimonti, A1
Gelibter, A1
Pavese, I1
Satta, F1
Cognetti, F1
Ferretti, G1
Rasio, D1
Vecchione, A1
Di Palma, M1
Rothenberg, ML1
Eckardt, JR1
Kuhn, JG1
Burris, HA1
Nelson, J1
Hilsenbeck, SG1
Rodriguez, GI1
Thurman, AM1
Smith, LS1
Eckhardt, SG1
Weiss, GR1
Elfring, GL1
Rinaldi, DA1
Schaaf, LJ2
Von Hoff, DD1
Saliba, F1
Hagipantelli, R1
Misset, JL1
Bastian, G1
Vassal, G1
Bonnay, M1
Herait, P1
Cote, C1
Mahjoubi, M1
Mignard, D1
Cvitkovic, E1
Cascinu, S1
Bichisao, E1
Amadori, D1
Silingardi, V1
Giordani, P1
Sansoni, E1
Luppi, G1
Catalano, V1
Agostinelli, R1
Catalano, G1
Pitot, HC1
Goldberg, RM1
Reid, JM1
Sloan, JA1
Skaff, PA1
Erlichman, C1
Rubin, J1
Burch, PA1
Adjei, AA1
Alberts, SA1
Elfring, G1
Miller, LL1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
LARCID: Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea[NCT00582426]Phase 3139 participants (Actual)Interventional2008-04-30Completed
Phase 1b Trial of 5-fluorouracil, Leucovorin, Irinotecan in Combination With Temozolomide (FLIRT) and Bevacizumab for the First-line Treatment of Patients With MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.[NCT04689347]Phase 118 participants (Anticipated)Interventional2021-01-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)

Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point. (NCT00582426)
Timeframe: Baseline to Day 168

InterventionUnits on a scale (Mean)
Octreotide Long Acting Release0.5
Standard Treatment3.4

Number of Episodes of Diarrhea by Patient

Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis. (NCT00582426)
Timeframe: 6 months overall

InterventionEpisodes/patients/day (Mean)
Octreotide Long Acting Release21.6
Standard Treatment20.4

Percentage of Participants Developing Diarrhea (Grade 1 to 4)

The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. (NCT00582426)
Timeframe: 6 month overall

InterventionPercentage of Participants (Number)
Octreotide Long Acting Release76.1
Standard Treatment78.9

Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea

For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered. (NCT00582426)
Timeframe: 6 months overall

InterventionPercentage of participants (Number)
Octreotide Long Acting Release26.9
Standard Treatment11.3

Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea

(NCT00582426)
Timeframe: 6 months overall

InterventionPercentage of Participants (Number)
Octreotide Long Acting Release4.5
Standard Treatment7.0

Percentage of Participants Who Need Opioids for Control of Diarrhea

(NCT00582426)
Timeframe: 6 months overall

InterventionPercentage of Participants (Number)
Octreotide Long Acting Release1.5
Standard Treatment1.4

Percentage of Patients Hospitalized Due to Diarrhea

(NCT00582426)
Timeframe: 6 months overall

InterventionPercentage of patients (Number)
Octreotide Long Acting Release6
Standard Treatment4.2

Number of Episodes of Diarrhea by Patient by Cycle

Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.) (NCT00582426)
Timeframe: at each cycle (28 days per cycle)

,
InterventionEpisodes/patient/cycle (Mean)
Cycle 1 (n=20, 18)Cycle 2 (n=36,38)Cycle 3 (n=33,39)Cycle 4 (n=24, 27)Cycle 5 (n=20,29)Cycle 6 (n=22, 22)Cycle 7 (n= 16, 20)
Octreotide Long Acting Release2.68.26.98.68.16.14.8
Standard Treatment2.25.96.77.175.86.6

Percentage of Episodes by Grade

Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. (NCT00582426)
Timeframe: 6 months overall

,
InterventionPercentage of Episodes (Number)
Grade 1Grade 2Grade 3Grade 4
Octreotide Long Acting Release65.423.311.30
Standard Treatment66.927.25.90

Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)

Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. (NCT00582426)
Timeframe: Day 56, Day 84, Day 112, Day 140, Day 168

,
InterventionPercentage of Participants (Number)
Day 56 (N=11,2)Day 84 (N=5,3)Day 112 (N=1,1)Day 140 (N=9,1)Day 168 (N=2,1)
Octreotide Long Acting Release45.560.010044.4100
Standard Treatment0.01000.0100100

Percentage of Patients by Grade of Diarrhea

Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. (NCT00582426)
Timeframe: 6 months overall

,
InterventionPercentage of Participants (Number)
Grade 1Grade 2Grade 3Grade 4
Octreotide Long Acting Release41.225.533.30
Standard Treatment26.851.821.40

Reviews

2 reviews available for loperamide and Colorectal Neoplasms

ArticleYear
Chronic diarrhoea in adults: what not to miss.
    Current opinion in gastroenterology, 2019, Volume: 35, Issue:3

    Topics: Adenocarcinoma; Adenoma; Antidiarrheals; Bile Acids and Salts; Celiac Disease; Chronic Disease; Colo

2019
New approaches to prevent intestinal toxicity of irinotecan-based regimens.
    Cancer treatment reviews, 2004, Volume: 30, Issue:6

    Topics: Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Col

2004

Trials

6 trials available for loperamide and Colorectal Neoplasms

ArticleYear
Effects of Modified Baizhu Shaoyao San on Postoperative Diarrhea in Colorectal Cancer Patients: A Single-Blind, Randomized Controlled Trial.
    Complementary medicine research, 2023, Volume: 30, Issue:1

    Topics: Colorectal Neoplasms; Diarrhea; Gastrins; Gastrointestinal Diseases; Humans; Loperamide; Motilin; Si

2023
Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: the LARCID trial.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Apr-01, Volume: 32, Issue:10

    Topics: Adult; Aged; Antidiarrheals; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Capecitab

2014
Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1996, Volume: 14, Issue:4

    Topics: Adenocarcinoma; Antidiarrheals; Antineoplastic Agents, Phytogenic; Camptothecin; Colorectal Neoplasm

1996
Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1998, Volume: 16, Issue:8

    Topics: Adult; Aged; Antidiarrheals; Antineoplastic Agents, Phytogenic; Camptothecin; Colorectal Neoplasms;

1998
High-dose loperamide in the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2000, Volume: 8, Issue:1

    Topics: Administration, Oral; Adult; Aged; Antidiarrheals; Antimetabolites, Antineoplastic; Antineoplastic C

2000
Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2000, Volume: 6, Issue:6

    Topics: Adjuvants, Anesthesia; Adult; Aged; Aged, 80 and over; Antidiarrheals; Antiemetics; Antineoplastic A

2000