The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy
- 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
- 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
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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
Amy LeJeune, MS, RD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|