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

NCT01644097 Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Stanford University
Phase	Phase 2
Status	WITHDRAWN
Start date	2012-11

Conditions

• Diarrhea
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

• Lactobacillus plantarum strain 299v
• Lactobacillus acidophilus probiotic
• placebo
• laboratory biomarker analysis
• questionnaire administration
• quality-of-life assessment
• Bifidobacterium lactis probiotic supplement

Primary outcomes

• Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0 — Up to 9 weeks
  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.
• FACIT-D Trial Outcome Index (TOI) — Up to 4 weeks post treatment
  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.

Countries

United States