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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Given PO
Given PO
Given PO
Stanford University
Stanford, California, United States
Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
Will be calculated by the percentage of patients experiencing grade 2-4 diarrhea as documented by patient diary and primary oncologist's documentation. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
Time frame: Up to 9 weeks
FACIT-D Trial Outcome Index (TOI)
The FACIT-D TOI has a range of scores from 0-100 which are a combination of physical well being, functional well being, and diarrhea subscale. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
Time frame: Up to 4 weeks post treatment
Dose delays or reductions due to GI toxicity
Time frame: Up to 9 weeks
Anti-diarrheal use
Time frame: Up to 9 weeks
Overall HR-QOL
Time frame: Up to 4 weeks post treatment
Febrile neutropenia
Time frame: Up to 4 weeks post treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 4 weeks post treatment
Overall survival
Time frame: Up to 2 years
Progression free survival
Time frame: Up to 2 years
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Ancillary studies
Given PO