Cervical Cancer, Diarrhea, Prostate Cancer, Radiation Toxicity, Sarcoma
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTdietary 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.
PROCEDUREmanagement of therapy complications
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
PROCEDUREquality-of-life assessment
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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\^®)
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed