Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.
Condition: Cervical Cancer; Diarrhea; Prostate Cancer; Radiation Toxicity; Sarcoma
MeSH terms: Prostatic Neoplasms; Sarcoma; Uterine Cervical Neoplasms; Diarrhea
Study type: Interventional

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.
    

Intervention name(s): dietary intervention; management of therapy complications; quality-of-life assessment
Intervention type(s): Dietary Supplement; Procedure; Procedure
Intervention description(s): At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks.; Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.; Interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
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