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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Diarrhea, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT01644097

Run by

Stanford University

People needed

0

Starts

2012-11-01

Last updated by the study team

2014-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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