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

Phase 4TerminatedNCT01189409

British Columbia Cancer Agency70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Constipation Cancer

Interventions

PEG then SennaDRUG

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 PEGDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

BC Cancer Agency

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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.

Time frame: Last 18 days of each 21 day study period

Secondary Outcomes

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 frame: end of study (6 weeks)

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.

Time frame: 3 weeks (ascertained at the end of period 1)

Incidence of Cramps

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

Rectal Measures

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

Data from ClinicalTrials.gov

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