Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
- Registration Number
- NCT01189409
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Senna then PEG Senna then PEG Stepped bowel protocol with Senna then PEG PEG then Senna PEG then Senna PEG in stepped bowel protocol
- Primary Outcome Measures
Name Time Method Bowel Performance Scale (BPS) 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.
- Secondary Outcome Measures
Name Time Method Time (in Days) to Attain an Ideal BPS Score of Goal 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.Rectal Measures 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
Incidence of Cramps Last 18 days of each 21 day study period The patients were asked to indicate any experience of cramps while on study treatment
Patient Preference 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).
Trial Locations
- Locations (1)
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada