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临床试验/NCT00258401
NCT00258401已完成不适用

The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy

Case Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

研究者

申办方类型
Other

研究点 (2)

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