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

Stanford University

Status and phase

Withdrawn

Phase 2

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Diarrhea

Treatments

Other: laboratory biomarker analysis

Dietary Supplement: Lactobacillus plantarum strain 299v

Dietary Supplement: Bifidobacterium lactis probiotic supplement

Dietary Supplement: placebo

Other: questionnaire administration

Dietary Supplement: Lactobacillus acidophilus probiotic

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01644097

NCI-2012-01127 (Registry Identifier)

VAR0084

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Arm I (probiotic mix)

Experimental group

Description:

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.

Treatment: