Managing Medication-induced Constipation in Cancer: A Clinical Trial

Constipation Clinical Trial

Official title:

Managing Medication-induced Constipation in Cancer: A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416909
• Other study ID #: MCC-15712
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: February 21, 2017
• Start date: November 2008
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• Laxative Treatment
Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
• Standard of Care
Participants will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.
• Assessment Questionnaires
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institutes of Health (NIH), University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I - Record Constipation Incidence and Symptoms	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.	18 months
Secondary	Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation	To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.	2 years, 3 months
Secondary	Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation	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.	2 years, 3 months

External Links

•   Moffitt Cancer Center Clinical Trials website