Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01473290
First received: November 15, 2011
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.


Condition Intervention Phase
Cognitive/Functional Effects
Constipation, Impaction, and Bowel Obstruction
Diarrhea
Fatigue
Gastrointestinal Complications
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: live freeze-dried lactic acid bacteria probiotic
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in the Prevention of Acute Enteritis in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE [ Designated as safety issue: No ]
  • Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
Dietary Supplement: live freeze-dried lactic acid bacteria probiotic
Given orally (PO)
Placebo Comparator: Arm II
Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
Other: placebo
Given PO

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether live freeze-dried lactic acid bacteria probiotic (VSL#3®) is effective in reducing the acute treatment-related bowel function disturbances, as measured by the FACIT-D diarrhea subscale score in patients receiving concurrent chemotherapy and pelvic RT as adjuvant or primary treatment for malignancy.

Secondary

  • To determine whether VSL#3® can reduce chronic treatment-related bowel dysfunction following completion of therapy.
  • To examine whether VSL#3® appears to have an impact on disease-free survival.
  • To bank blood products for future studies. (exploratory)
  • To characterize changes in the fecal microbiota and examine for correlation with treatment assignment and symptom scores. (exploratory)

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of primary tumor (rectum/anus vs other), history of anterior resection of the rectum (yes vs no), total planned cumulative dose (including boost of external-beam radiotherapy [RT] or brachytherapy) (4,500-5,350 cGy vs > 5,350 cGy), and use of intensity-modulated RT [IMRT] for pelvic RT (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
  • Arm II: Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.

Patients self-report symptoms using the FACIT-D, PBFQ, PRO-CTCAE, and Uniscale/fatigue weekly during RT, for 2 weeks after completion of RT, and at 12 months following the completion of RT.

Blood and stool samples may be collected from some patients for correlative studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam radiotherapy (RT) to the pelvis to a minimum dose of 4,500 cGy with the following parameters:

    • The pelvis must be encompassed by the planned RT fields

      • The superior border may not lie inferior to the most inferior aspect of the sacroiliac joints
      • Portions of the rectum may have special blocking, depending upon disease site
    • The total prescription dose must lie between 4,500-5,350 cGy (inclusive)

      • A boost to primary tumor or tumor bed may be planned
    • Planned treatment is to be given 4-5 times per week on a one- treatment-per-day basis

      • The daily prescribed dose must lie between 170-210 cGy (inclusive) per day
    • No planned split-course RT
    • No proton RT
  • Will receive concurrent administration of chemotherapy (fluorouracil, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin C) during pelvic RT
  • No current or prior metastases beyond regional lymph nodes

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) of 0, 1, or 2
  • Life expectancy ≥ 6 months
  • Able to complete questionnaire(s) by themselves or with assistance
  • Not pregnant or nursing
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • Fertile patients must use effective contraception
  • Hemoglobin > 10.0 g/dL
  • White blood cells (WBC) > 3,500/mm³
  • Absolute neutrophil count (ANC) > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
  • No known allergy to a probiotic preparation
  • No history of inflammatory bowel disease
  • No ≥ grade 3 diarrhea, ≥ grade 3 rectal bleeding, abdominal cramping, or incontinence of stool ≤ 7 days prior to registration
  • No medical condition that may interfere with ability to receive protocol treatment
  • No history of gastrointestinal or genitourinary obstruction or porphyria
  • No history of irritable bowel syndrome (IBS)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
  • No planned use of leucovorin
  • No prior pelvic RT
  • No use of probiotics ≤ 2 weeks prior to registration
  • No use of antibiotics ≤ 3 days prior to registration
  • No planned continuous antibiotic treatment during RT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473290

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Robert C. Miller, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT01473290     History of Changes
Other Study ID Numbers: CDR0000716291, NCCTG-N10CB
Study First Received: November 15, 2011
Last Updated: May 9, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
diarrhea
constipation, impaction, and bowel obstruction
gastrointestinal complications
fatigue
psychosocial effects of cancer and its treatment
cognitive/functional effects
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Constipation
Diarrhea
Fatigue
Fecal Impaction
Intestinal Obstruction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014