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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind using a dummy alternate treatment.

Study Groups

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PEG then Senna

PEG in stepped bowel protocol

Group Type EXPERIMENTAL

PEG then Senna

Intervention Type DRUG

Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Senna then PEG

Stepped bowel protocol with Senna then PEG

Group Type EXPERIMENTAL

Senna then PEG

Intervention Type DRUG

Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Lax-a-Day senokot

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No