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

Trial ID or NCT#

NCT01644097

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Denise Haas
650-736-1252

View on ClinicalTrials.gov