Status:
COMPLETED
Managing Medication-induced Constipation in Cancer: A Clinical Trial
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
University of South Florida
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Patients will undergo a baseline assessment during their regular outpatient visit. With their permission, the investigators will audio record this visit for quality control. After the study, the recor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT01416909
Start Date
November 1 2008
End Date
January 1 2014
Last Update
February 23 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612