Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
NCT ID: NCT01644097
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
NCT01473290
Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
NCT06772090
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
NCT03072641
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
NCT06892093
To Evaluate the Clinical Efficacy of Probiotics in Patients with the Breast Cancer
NCT06039644
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Incidence of moderate/severe (grade 2-4) diarrhea graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Trial Outcome Index.
SECONDARY OBJECTIVES:
I. To evaluate the effects of probiotic supplementation on dose delays or reductions due to gastrointestinal (GI) toxicity.
II. To evaluate the effects of probiotic supplementation on anti-diarrheal medication use.
III. To evaluate the effects of probiotic supplementation on overall health-related quality of life (HR-QOL).
IV. To evaluate the effects of probiotic supplementation on febrile neutropenia.
V. To evaluate the effects of probiotic supplementation on adverse GI effects. VI. To evaluate the effects of probiotic supplementation on overall survival. VII. To evaluate the effects of probiotic supplementation on progression free survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic orally (PO) twice daily (BID) for 9 weeks. Treatment continues in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (probiotic mix)
Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic PO BID for 9 weeks. Treatment continues in the absence of unacceptable toxicity.
Lactobacillus plantarum strain 299v
Given PO
Lactobacillus acidophilus probiotic
Given PO
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Bifidobacterium lactis probiotic supplement
Given PO
Arm II (placebo)
Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
placebo
Given PO
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lactobacillus plantarum strain 299v
Given PO
Lactobacillus acidophilus probiotic
Given PO
placebo
Given PO
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Bifidobacterium lactis probiotic supplement
Given PO
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Russell Pachynski
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-01127
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAR0084
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.