NCT01473290

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

First QC Date

November 15, 2011

Last Update Submit

July 1, 2016

Conditions

Cognitive/Functional EffectsConstipation, Impaction, and Bowel ObstructionDiarrheaFatigueGastrointestinal ComplicationsPsychosocial Effects of Cancer and Its TreatmentUnspecified Adult Solid Tumor, Protocol Specific

Keywords

diarrheaconstipation, impaction, and bowel obstructiongastrointestinal complicationsfatiguepsychosocial effects of cancer and its treatmentcognitive/functional effectsunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 12 months

Secondary Outcomes (3)

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

    Up to 12 months

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

    Up to 12 months

  • Disease-free survival

    Up to 12 months

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

PLACEBO COMPARATOR

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

Other: placebo

Interventions

live freeze-dried lactic acid bacteria probioticDIETARY_SUPPLEMENT

Given orally (PO)

Arm I
placeboOTHER

Given PO

Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

ConstipationIntestinal ObstructionDiarrheaFatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Robert C. Miller, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 17, 2011

Last Updated

July 6, 2016

Record last verified: 2016-07