Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherap… (NCT01473290) | Clinical Trial Compass
WithdrawnPhase 3
Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
Stopped: The study was not activated.
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Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/mmÂł
* Absolute neutrophil count (ANC) \>…
What they're measuring
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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