Clinical trial · Interventional
Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
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
NCT01473290CI-TRIAL-00022847withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was not activated.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Constipation, Impaction, and Bowel Obstruction | — | UNRESOLVED | — |
| Diarrhea | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Gastrointestinal Complications | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| live freeze-dried lactic acid bacteria probiotic | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Dietary Supplement: live freeze-dried lactic acid bacteria probiotic
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
- interventionNames
- Other: placebo
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 RTReferences
Publications (0)
Data not yet available
No reference posted for this study.