Clinical Trial: Managing Medication-induced Constipation in Cancer: A Clinical Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Managing Medication-induced Constipation in Cancer: A Clinical Trial

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 Summary: 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.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Phase I - Record Constipation Incidence and Symptoms [ Time Frame: 18 months ]

Original Primary Outcome:

• Phase I - Record of Each Participant's Constipation Incidents and Their Corresponding Opioid Dose [ Time Frame: 18 months ]
  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.
• Phase I - Record of Each Participant's Constipation Intensity and Their Vinca Alkaloid Dose [ Time Frame: 18 months ]
  Relationship Between Constipation Intensity and Vinca Alkaloid 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 over an 8 week period and to evaluate the relationship between intensity and vinca alkaloid dose.

Current Secondary Outcome:

• Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome:

• Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation [ Time Frame: 2 years, 3 months ]
  To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.
• Phase II - Number of Participants With Desired Determination of Dose - Ongoing Assessment Group [ Time Frame: 2 years, 3 months ]
  Best Determination of Laxative Dose for Opioid Group. To test whether laxative dose is best determined based on on-going assessment or on opioid dose.
• Phase II - Number of Participants With Desired Determination of Dose - Opioid Dose Group [ Time Frame: 2 years, 3 months ]
  Best Determination of Laxative Dose for Opioid Group. To test whether laxative dose is best determined based on on-going assessment or on opioid dose.

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: August 11, 2011
Date Started: November 2008
Date Completion:
Last Updated: February 21, 2017
Last Verified: March 2015