NCT01644097

Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy

A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus plantarum strain 299v	Given PO
DIETARY_SUPPLEMENT	Lactobacillus acidophilus probiotic	Given PO
DIETARY_SUPPLEMENT	placebo	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
DIETARY_SUPPLEMENT	Bifidobacterium lactis probiotic supplement	Given PO

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-09-01
• First posted: 2012-07-18
• Last updated: 2014-02-14

Locations

1 site across 1 country: United States