Managing Medication-induced Constipation in Cancer: A Clinical Trial (NCT01416909) | Clinical Trial Compass
CompletedNot Applicable
Managing Medication-induced Constipation in Cancer: A Clinical Trial
United States601 participantsStarted 2008-11
Plain-language summary
The purpose of this research is to evaluate the effectiveness of the Constipation Treatment Protocol and to test whether management according to dose of constipation-inducing medications or according to on-going assessment is most effective.
Who can participate
Age range
18 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.
Inclusion Criteria:
* The study sample will consist of patients who are receiving outpatient care at the Moffitt Cancer Center.
* Patients will be identified as those who have a diagnosis of cancer and are being treated with either opioids or vinca alkaloids,
* are adults (or children 18-21 years old),
* either male or female,
* able to read and understand English,
* and able to pass screening with the Short Portable Mental Status Questionnaire and Karnofsky Performance Status Scale.
Exclusion Criteria:
* Patients will be excluded: if they have non-melanoma skin cancer or colorectal or gynecological cancer as their primary diagnosis;
* if they are excessively debilitated or deemed unlikely to survive for the eight weeks of the data collection period;
* if they are unable to read and understand English;
* if they have an ostomy that changes bowel function;
* if they have a current peritoneal catheter;
* if they have had abdominal surgery within the past six weeks;
* or have a disease process suggestive of mechanical obstruction (tumor or adhesion);
* if they have a history of chronic bowel disease (including irritable bowel syndrome, chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or diarrhea as a result of radiation to the pelvis), or report chronic laxative use prior to cancer onset.
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
Phase I - Record Constipation Incidence and Symptoms
Timeframe: 18 months
Trial details
NCT IDNCT01416909
SponsorH. Lee Moffitt Cancer Center and Research Institute