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

Not Recruiting

Trial ID: NCT01644097


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.

Official Title

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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Any patient with a documented malignancy initiating treatment including (as a single
   agent or in combination with other drugs) any one of the following cancer

   o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel,
   crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib

   - Any pathologically confirmed malignancy for which the patient would receive any of the
   listed cancer therapeutics

   - Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2

   - Patient must have an estimated life expectancy of at least 6 months

   - Absolute neutrophil count (ANC) > 1500

   - Platelets > 100K

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN (upper
   limit normal)

   - Serum bilirubin < 1.5 x ULN

   - Serum creatinine < 1.5 x ULN

   - Ability to understand and the willingness to sign a written informed consent document
   and comply with the treatment protocol

Exclusion Criteria:

   - Patients currently undergoing treatment with the above listed therapeutics at time of
   initiation of trial; patients can have had prior treatment(s) with one or more of the
   agents if they are initiating a new treatment with another agent on the list, provided
   they have had at least a 2 week "washout" period

   - Patients currently taking anti-diarrheal medications or therapy

   - Patients undergoing hemodialysis

   - Patients with known allergic or hypersensitivity reaction to probiotics, yoghurt, or
   similar diet or supplemental products

   - Acute or chronic diarrhea, including lactose intolerance, gluten or other dietary
   sensitivity resulting in gastrointestinal symptoms

   - Pregnant or nursing patients

   - Known human immunodeficiency virus (HIV) positive

   - Prior abdominal surgery resulting in a stoma, ostomy, fistula, or other anatomic

   - Concurrent or near future radiotherapy; prior, completed radiotherapy allowed; any
   radiotherapy within the vicinity of the GI tract must have been completed at least 4
   weeks prior to start of trial

   - Treatment with any investigational drug within 4 weeks prior to enrollment

   - Current treatment with antibiotics or other gut motility agents within 2 weeks of
   starting study medication

   - Abnormal thyroid function that is not controlled with medication

   - Patients taking other dietary supplements within 2 weeks of starting study medication

   - Any other serious or uncontrolled illness which, in the opinion of the investigator,
   makes it undesirable for the patient to enter the trial


dietary supplement: Lactobacillus plantarum strain 299v

dietary supplement: Lactobacillus acidophilus probiotic

dietary supplement: placebo

other: laboratory biomarker analysis

other: questionnaire administration

procedure: quality-of-life assessment

dietary supplement: Bifidobacterium lactis probiotic supplement

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas

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