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

Primary Purpose

Constipation, Cancer

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PEG then Senna
Senna then PEG
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring Constipation, Opioids, Cancer, Polyethylene glycol, Sennosides, Opioid Therapy

Eligibility Criteria

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

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.

Sites / Locations

  • BC Cancer Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEG then Senna

Senna then PEG

Arm Description

PEG in stepped bowel protocol

Stepped bowel protocol with Senna then PEG

Outcomes

Primary Outcome Measures

Bowel Performance Scale (BPS)
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.

Secondary Outcome Measures

Patient Preference
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).
Time (in Days) to Attain an Ideal BPS Score of Goal
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.
Incidence of Cramps
The patients were asked to indicate any experience of cramps while on study treatment
Rectal Measures
The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment

Full Information

First Posted
March 17, 2010
Last Updated
August 20, 2019
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01189409
Brief Title
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated based on results of interim analysis.
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Cancer
Keywords
Constipation, Opioids, Cancer, Polyethylene glycol, Sennosides, Opioid Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The primary outcome will be treated as a binomial outcome, expressed as the number of successful trials out of a pre-defined number of trials n = 18. Given this, the primary outcome will be analysed via a generalized mixed effects model. The model will include: (i) fixed effects for treatment, treatment period and their interaction, (ii) fixed effects for the baseline characteristics and (iii) a random patient effect. Including the latter effect in the model will help capture the within-patient correlation among the values of the primary outcome collected in Period I and Period II for the same patient. All statistical analyses will be conducted using the open-source statistical software package R.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind using a dummy alternate treatment.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEG then Senna
Arm Type
Experimental
Arm Description
PEG in stepped bowel protocol
Arm Title
Senna then PEG
Arm Type
Experimental
Arm Description
Stepped bowel protocol with Senna then PEG
Intervention Type
Drug
Intervention Name(s)
PEG then Senna
Other Intervention Name(s)
Lax-a-Day
Intervention Description
Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Intervention Type
Drug
Intervention Name(s)
Senna then PEG
Other Intervention Name(s)
senokot
Intervention Description
Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Primary Outcome Measure Information:
Title
Bowel Performance Scale (BPS)
Description
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.
Time Frame
Last 18 days of each 21 day study period
Secondary Outcome Measure Information:
Title
Patient Preference
Description
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).
Time Frame
end of study (6 weeks)
Title
Time (in Days) to Attain an Ideal BPS Score of Goal
Description
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.
Time Frame
3 weeks (ascertained at the end of period 1)
Title
Incidence of Cramps
Description
The patients were asked to indicate any experience of cramps while on study treatment
Time Frame
Last 18 days of each 21 day study period
Title
Rectal Measures
Description
The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
Time Frame
Last 18 days of each 21 day study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient (18 years and above) with diagnosis of cancer. Patient requires treatment or prevention of constipation. Patient is able to communicate effectively with staff. Expected prognosis more than 12 weeks. On or starting opioid therapy Exclusion Criteria: Patient unable to take oral medication. Allergy or previous intolerance to PEG or sennosides. Lactose intolerant. Contraindication to PEG or sennosides. Known or suspected bowel obstruction or ileus. Colostomy or ileostomy. Inflammatory bowel disease. Hospitalisation expected within the study period. Patient unable to complete the study diary in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippa Hawley, FRCPC
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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