Back to results

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

Primary Purpose

Cognitive/Functional Effects, Constipation, Impaction, and Bowel Obstruction, Diarrhea

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

live freeze-dried lactic acid bacteria probiotic

placebo

About this trial

This is an interventional supportive care trial for Cognitive/Functional Effects focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.

Outcomes

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

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

Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE

Disease-free survival

Full Information

NCT ID

NCT01473290

First Posted

November 15, 2011

Last Updated

July 1, 2016

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01473290

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Withdrawn

Why Stopped

The study was not activated.

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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 Title

Arm II

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.

Intervention Type

Dietary Supplement

Intervention Name(s)

live freeze-dried lactic acid bacteria probiotic

Intervention Description

Given orally (PO)

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE

Time Frame

Up to 12 months

Title

Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE

Time Frame

Up to 12 months

Title

Disease-free survival

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert C. Miller, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs