Spots Global Cancer Trial Database for Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy

Study Description

Brief Summary: This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.

Detailed Description: PRIMARY OBJECTIVES: I. Incidence of moderate/severe (grade 2-4) diarrhea graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. II. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Trial Outcome Index. SECONDARY OBJECTIVES: I. To evaluate the effects of probiotic supplementation on dose delays or reductions due to gastrointestinal (GI) toxicity. II. To evaluate the effects of probiotic supplementation on anti-diarrheal medication use. III. To evaluate the effects of probiotic supplementation on overall health-related quality of life (HR-QOL). IV. To evaluate the effects of probiotic supplementation on febrile neutropenia. V. To evaluate the effects of probiotic supplementation on adverse GI effects. VI. To evaluate the effects of probiotic supplementation on overall survival. VII. To evaluate the effects of probiotic supplementation on progression free survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic orally (PO) twice daily (BID) for 9 weeks. Treatment continues in the absence of unacceptable toxicity. ARM II: Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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