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

Primary Purpose

Diarrhea, Unspecified Adult Solid Tumor, Protocol Specific

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus plantarum strain 299v
Lactobacillus acidophilus probiotic
placebo
laboratory biomarker analysis
questionnaire administration
quality-of-life assessment
Bifidobacterium lactis probiotic supplement
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diarrhea focused on measuring Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (probiotic mix)

Arm II (placebo)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Dose delays or reductions due to GI toxicity
Anti-diarrheal use
Overall HR-QOL
Febrile neutropenia
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Overall survival
Progression free survival

Full Information

First Posted
July 12, 2012
Last Updated
February 12, 2014
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01644097
Brief Title
Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
Official Title
A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
issues with obtaining study product
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (probiotic mix)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum strain 299v
Other Intervention Name(s)
DSM 9843, Lp 299v
Intervention Description
Given PO
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus acidophilus probiotic
Intervention Description
Given PO
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium lactis probiotic supplement
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
Description
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.
Time Frame
Up to 9 weeks
Title
FACIT-D Trial Outcome Index (TOI)
Description
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.
Time Frame
Up to 4 weeks post treatment
Secondary Outcome Measure Information:
Title
Dose delays or reductions due to GI toxicity
Time Frame
Up to 9 weeks
Title
Anti-diarrheal use
Time Frame
Up to 9 weeks
Title
Overall HR-QOL
Time Frame
Up to 4 weeks post treatment
Title
Febrile neutropenia
Time Frame
Up to 4 weeks post treatment
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Up to 4 weeks post treatment
Title
Overall survival
Time Frame
Up to 2 years
Title
Progression free survival
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Pachynski
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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