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

NCT01644097 | Withdrawn Phase 2 DMC

• 2 other identifiers: VAR0084NCI-2012-01127
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (2)

• Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0

  Will be calculated by the percentage of patients experiencing grade 2-4 diarrhea as documented by patient diary and primary oncologist's documentation. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.

  Up to 9 weeks

• FACIT-D Trial Outcome Index (TOI)

  The FACIT-D TOI has a range of scores from 0-100 which are a combination of physical well being, functional well being, and diarrhea subscale. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.

  Up to 4 weeks post treatment

Secondary Outcomes (7)

• Dose delays or reductions due to GI toxicity

  Up to 9 weeks

• Anti-diarrheal use

  Up to 9 weeks

• Overall HR-QOL

  Up to 4 weeks post treatment

• Febrile neutropenia

  Up to 4 weeks post treatment

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to 4 weeks post treatment

Study Arms (2)

Arm I (probiotic mix)

EXPERIMENTAL

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.

Dietary Supplement: Lactobacillus plantarum strain 299v; Dietary Supplement: Lactobacillus acidophilus probiotic; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment; Dietary Supplement: Bifidobacterium lactis probiotic supplement

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.

Dietary Supplement: placebo; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment

Interventions

Lactobacillus plantarum strain 299v DIETARY_SUPPLEMENT

Given PO

Also known as: DSM 9843, Lp 299v

Arm I (probiotic mix)

Lactobacillus acidophilus probiotic DIETARY_SUPPLEMENT

Given PO

Arm I (probiotic mix)

placebo DIETARY_SUPPLEMENT

Given PO

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (probiotic mix); Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (probiotic mix); Arm II (placebo)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (probiotic mix); Arm II (placebo)

Bifidobacterium lactis probiotic supplement DIETARY_SUPPLEMENT

Given PO

Arm I (probiotic mix)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell Pachynski

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 18, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)