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
18 Years
N/A
Both
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
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Robert C. Miller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
Unspecified
Study ID:
CDR0000716291
NCT ID:
NCT01473290
Start Date:
December 2011
Completion Date:
Related Keywords:
- 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
- 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
- Constipation
- Diarrhea
- Fatigue
- Fecal Impaction
- Intestinal Obstruction
Name | Location |
|---|
