Education and Training
Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- 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
Eligibility
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
therapeutics:
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
defect
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
650-736-1252
Not Recruiting