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

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

Sponsors

Lead Sponsor: British Columbia Cancer Agency

Source British Columbia Cancer Agency
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.

Overall Status Terminated
Start Date June 2010
Completion Date October 2018
Primary Completion Date December 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Bowel Performance Scale (BPS) Last 18 days of each 21 day study period
Secondary Outcome
Measure Time Frame
Patient Preference end of study (6 weeks)
Time (in Days) to Attain an Ideal BPS Score of Goal 3 weeks (ascertained at the end of period 1)
Incidence of Cramps Last 18 days of each 21 day study period
Rectal Measures Last 18 days of each 21 day study period
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: PEG then Senna

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).

Arm Group Label: PEG then Senna

Other Name: Lax-a-Day

Intervention Type: Drug

Intervention Name: Senna then PEG

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).

Arm Group Label: Senna then PEG

Other Name: senokot

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Philippa Hawley, FRCPC Principal Investigator British Columbia Cancer Agency
Location
Facility: BC Cancer Agency
Location Countries

Canada

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: British Columbia Cancer Agency

Investigator Full Name: Pippa Hawley

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PEG then Senna

Type: Experimental

Description: PEG in stepped bowel protocol

Label: Senna then PEG

Type: Experimental

Description: Stepped bowel protocol with Senna then PEG

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention 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.

Primary Purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double blind using a dummy alternate treatment.

Source: ClinicalTrials.gov