The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Not specified
- •Not specified
- •Gastrointestinal
- •No enteric support
- •No inflammatory bowel disease
- •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
- •No prior colectomy
- •No concurrent glutamine, psyllium, or other fiber supplements (e.g., Benefiber^® or Metamucil^®)
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: dietary intervention (Dietary Supplement)
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.
干预措施: management of therapy complications (Procedure)
no dietary intervention
At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.
干预措施: management of therapy complications (Procedure)
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.
干预措施: quality-of-life assessment (Procedure)
no dietary intervention
At the onset of diarrhea symptoms, patients undergo no dietary intervention but are interviewed weekly for up to six weeks.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks
时间窗: baseline and once a week for 6 weeks
次要结局
未报告次要终点