Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.

Study Overview
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Brief Summary
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RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products) may help prevent or reduce diarrhea caused by pelvic radiation therapy. PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it works compared to no dietary intervention in treating diarrhea in patients who are undergoing radiation therapy to the pelvis for uterine, cervical, or prostate cancer.

Detailed Description
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OBJECTIVES: Compare the nutritional status, Common Toxicity Criteria (CTC) score, and fecal incontinence quality of life (FI-QOL) in patients with uterine, cervical, or prostate cancer who are undergoing pelvic radiotherapy receiving a low-residue diet vs no dietary intervention. Compare changes in the CTC score and FI-QOL in patients receiving a low-residue diet vs no dietary intervention. Compare the efficacy, in terms of a lower CTC score or higher perceived FI-QOL, of a low-residue diet vs no dietary intervention in these patients. OUTLINE: This is a parallel, randomized, controlled, pilot study. Patients are stratified according to cancer type. Patients are randomized to 1 of 2 treatment arms. All patients are interviewed to obtain a baseline grade of diarrhea (according to NCI's Common Toxicity Criteria [CTC] scale) and dietary history and measure Fecal Incontinence Quality of Life (FI-QOL). Arm I (intervention): At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks. They are interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores. Arm II (control): Patients undergo no dietary intervention but are interviewed as in arm I. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy

Conditions
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Cervical Cancer, Diarrhea, Prostate Cancer, Radiation Toxicity, Sarcoma

Intervention / Treatment
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* Dietary Supplement: dietary intervention
* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of uterine, cervical, or prostate cancer Current patient at the Ireland/Case Comprehensive Cancer Center Planning pelvic radiation therapy within the next 4 months PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Gastrointestinal No enteric support No inflammatory bowel disease Other No other concurrent illness or medical condition that would preclude study compliance No history of allergies or dietary intolerances (e.g., lactose intolerance) that would preclude study treatment or interfere with study results PRIOR CONCURRENT THERAPY: Chemotherapy No concurrent chemotherapy Endocrine therapy Concurrent hormonal therapy allowed (e.g., testosterone suppression) Radiotherapy See Disease Characteristics Surgery No prior colectomy Other No concurrent glutamine, psyllium, or other fiber supplements (e.g., Benefiber^® or Metamucil^®)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low-residue diet<br>At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.Patients are interviewed weekly for up to six weeks. | Dietary Supplement: dietary intervention<br>* At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.<br>Procedure: management of therapy complications<br>* Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.<br>Procedure: quality-of-life assessment<br>* Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.<br>|
| Active Comparator: no dietary intervention<br>At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks. | Procedure: management of therapy complications<br>* Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.<br>Procedure: quality-of-life assessment<br>* Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks |  | baseline and once a week for 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, radiation toxicity, recurrent uterine sarcoma, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent cervical cancer, stage 0 cervical cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer