Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy. (NCT00258401) | Clinical Trial Compass
CompletedNot Applicable
Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.
United States11 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Hepatic
* Not specified
Renal
* Not specified
Gastrointestinal
* No enteric support
* No inflammatory bowel disease
Other
* 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
Surgery
* No prior colectomy
Other
* No concurrent glutamine, psyllium, or other fiber supplements (e.g., Benefiber\^® or Metamucil\^®)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diarrhea as assessed by Fecal Incontinence Questionnaire and CTC v3.0 at baseline and once a week for 6 weeks