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Managing Medication-induced Constipation in Cancer: A Clinical Trial

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

Managing Medication-induced Constipation in Cancer: A Clinical Trial

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Phase I - Record of Each Participant's Constipation Incidents and Their Corresponding Opioid Dose

Outcome Description:

Relationship Between Constipation Intensity and Opioid Dose. To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an 8 week period and to evaluate the relationships between constipation intensity and opioid dose.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Susan McMillan, Ph.D., RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

September 2013

Related Keywords:

  • Constipation
  • Medication-induced
  • Constipation in Cancer
  • Constipation



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612