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 range18 Years
SexALL
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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.
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