search
Back to results

Managing Medication-induced Constipation in Cancer: A Clinical Trial

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laxative Treatment
Standard of Care
Assessment Questionnaires
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring Medication-induced, Constipation in Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Other

Active Comparator

Other

Arm Label

Dose Intervention - Opioid

Assessment Intervention - Opioid

Control Group - Opioid

Assessment Intervention - Vinca Alkaloid

Control Group - Vinca Alkaloid

Arm Description

Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on the dose of the opioid pain medication they are receiving.

Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be determined based on their severity of constipation.

Standard of Care: Participants Receiving Opioids for the Treatment of Pain 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.

Laxative Treatment: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on their level of constipation.

Standard of Care: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Patients will receive standard of care 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 11, 2011
Last Updated
February 21, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH), University of South Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT01416909
Brief Title
Managing Medication-induced Constipation in Cancer: A Clinical Trial
Official Title
Managing Medication-induced Constipation in Cancer: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH), University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Medication-induced, Constipation in Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Intervention - Opioid
Arm Type
Active Comparator
Arm Description
Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on the dose of the opioid pain medication they are receiving.
Arm Title
Assessment Intervention - Opioid
Arm Type
Active Comparator
Arm Description
Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be determined based on their severity of constipation.
Arm Title
Control Group - Opioid
Arm Type
Other
Arm Description
Standard of Care: Participants Receiving Opioids for the Treatment of Pain 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.
Arm Title
Assessment Intervention - Vinca Alkaloid
Arm Type
Active Comparator
Arm Description
Laxative Treatment: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on their level of constipation.
Arm Title
Control Group - Vinca Alkaloid
Arm Type
Other
Arm Description
Standard of Care: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Patients will receive standard of care 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.
Intervention Type
Other
Intervention Name(s)
Laxative Treatment
Other Intervention Name(s)
constipation treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment Questionnaires
Intervention Description
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).
Primary Outcome Measure Information:
Title
Phase I - Record Constipation Incidence and Symptoms
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation
Description
To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.
Time Frame
2 years, 3 months
Title
Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation
Description
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.
Time Frame
2 years, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan McMillan, Ph.D., RN
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Managing Medication-induced Constipation in Cancer: A Clinical Trial

We'll reach out to this number within 24 hrs