Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

August 20, 2019 updated by: Pippa Hawley, British Columbia Cancer Agency

A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer

This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

One group will be started on a bowel protocol of escalating doses of sennosides, plus a dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules (lactose) plus polyethylene glycol, with the same dosing protocol. After three weeks of one active treatment the patients will switch to the alternate active product and dummy preparation. The total duration for the study will be 6 weeks for each patient.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patient (18 years and above) with diagnosis of cancer.
  2. Patient requires treatment or prevention of constipation.
  3. Patient is able to communicate effectively with staff.
  4. Expected prognosis more than 12 weeks.
  5. On or starting opioid therapy

Exclusion Criteria:

  1. Patient unable to take oral medication.
  2. Allergy or previous intolerance to PEG or sennosides.
  3. Lactose intolerant.
  4. Contraindication to PEG or sennosides.
  5. Known or suspected bowel obstruction or ileus.
  6. Colostomy or ileostomy.
  7. Inflammatory bowel disease.
  8. Hospitalisation expected within the study period.
  9. Patient unable to complete the study diary in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEG then Senna
PEG in stepped bowel protocol
Drug: PEG then Senna
Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Other Names:
  • Lax-a-Day
Experimental: Senna then PEG
Stepped bowel protocol with Senna then PEG
Drug: Senna then PEG
Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Other Names:
  • senokot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Performance Scale (BPS)
Time Frame: Last 18 days of each 21 day study period
Mean values of Number of Days with Satisfactory Bowel Movements Per Days of Treatment across time by treatment, derived from the mixed effects Poisson regression model. If the BPS rating on a day was -1, 0 or +1, the patient's bowel movement on that day was deemed to be satisfactory.
Last 18 days of each 21 day study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference
Time Frame: end of study (6 weeks)
The patients will be asked to state which treatment period they prefer. Only assessed using patients who completed both arms of the study (n=28).
end of study (6 weeks)
Time (in Days) to Attain an Ideal BPS Score of Goal
Time Frame: 3 weeks (ascertained at the end of period 1)

Proportion of patients in the study population estimated to reach a BPS at goal in the first period as a function of the time (in days) from day 1, presuming they were followed for 21 days and contributed a BPS score on each of those days.

Constipation was graded using the Victoria Bowel Performance Scale (BPS), a nine-point scale from -4 (constipation) to +4 (diarrhea) which has been validated for use in patients receiving palliative care.
3 weeks (ascertained at the end of period 1)
Incidence of Cramps
Time Frame: Last 18 days of each 21 day study period
The patients were asked to indicate any experience of cramps while on study treatment
Last 18 days of each 21 day study period
Rectal Measures
Time Frame: Last 18 days of each 21 day study period
The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
Last 18 days of each 21 day study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Philippa Hawley, FRCPC, British Columbia Cancer Agency

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H0901329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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