Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258401
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2005-11-22
Brief Title:
Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
The Effectiveness of a Low-Residue Diet on Diarrhea in Cancer Patients Receiving Pelvic Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 NCIs 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
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 NCIs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None