Managing Medication-induced Constipation in Cancer: A Clinical Trial

Completed · Not applicable

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT01416909

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

601

Starts

2008-11-01

Expected to finish

2014-01-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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