Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
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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.
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Compare changes in the CTC score and FI-QOL in patients receiving a low-residue diet vs no dietary intervention.
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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).
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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.
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Arm II (control): Patients undergo no dietary intervention but are interviewed as in arm
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: low-residue diet 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
At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.
Procedure: management 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.
Procedure: quality-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.
|
| Active Comparator: no dietary intervention 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
Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Procedure: quality-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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of uterine, cervical, or prostate cancer
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Current patient at the Ireland/Case Comprehensive Cancer Center
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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
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No other concurrent illness or medical condition that would preclude study compliance
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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®)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Study Chair: Amy LeJeune, MS, RD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE2Z05