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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01644097
Recruitment Status : Withdrawn (issues with obtaining study product)
First Posted : July 18, 2012
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diarrhea Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: Lactobacillus plantarum strain 299v Dietary Supplement: Lactobacillus acidophilus probiotic Dietary Supplement: placebo Other: laboratory biomarker analysis Other: questionnaire administration Procedure: quality-of-life assessment Dietary Supplement: Bifidobacterium lactis probiotic supplement Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
Study Start Date : November 2012
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Lactobacillus plantarum strain 299v
Given PO
Other Names:
  • DSM 9843
  • Lp 299v

Dietary Supplement: Lactobacillus acidophilus probiotic
Given PO

Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Dietary Supplement: Bifidobacterium lactis probiotic supplement
Given PO
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
 Dietary Supplement: placebo
Given PO
Other Name: PLCB

Other: laboratory biomarker analysis
Correlative studies

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0 [ Time Frame: Up to 9 weeks ]
    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.

  2. FACIT-D Trial Outcome Index (TOI) [ Time Frame: Up to 4 weeks post treatment ]
    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 :
  1. Dose delays or reductions due to GI toxicity [ Time Frame: Up to 9 weeks ]
  2. Anti-diarrheal use [ Time Frame: Up to 9 weeks ]
  3. Overall HR-QOL [ Time Frame: Up to 4 weeks post treatment ]
  4. Febrile neutropenia [ Time Frame: Up to 4 weeks post treatment ]
  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 4 weeks post treatment ]
  6. Overall survival [ Time Frame: Up to 2 years ]
  7. Progression free survival [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644097


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Russell Pachynski Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01644097    
Other Study ID Numbers: VAR0084
NCI-2012-01127 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Stanford University:
Quality of Life
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive