Managing Medication-induced Constipation in Cancer: A Clinical Trial

Not Applicable

Completed

• Conditions: Constipation

• Registration Number: NCT01416909
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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 to on-going assessment is most effective.

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 recordings will be erased. Patients will be asked to complete 4 questionnaires. The investigators will collect contact information so that the follow-up assessments can be done by phone.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Primary Completion: 2013-08
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Phase I - Record Constipation Incidence and Symptoms	18 months	To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an eight week period and to evaluate the relationships between constipation intensity and opioid dose.; To identify the incidence, severity, distress and trajectory of constipation in groups of cancer patients who may be at risk due to vinca alkaloids (vincristine. vinblastine. vinorelbine and vindesine) over an eight week period and to evaluate the relationship between constipation intensity and vinca alkaloid dose.

Secondary Outcome Measures

Name	Time	Method
Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation	2 years, 3 months	To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.
Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation	2 years, 3 months	To test whether laxative dose is best determined based on on-going assessment or on opioid dose.; To test whether laxative dose is best determined based on on-going assessment or on vinca alkaloid dose.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States