Clinical trial NCT01189409: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Constipation
Cancer
Keywords: Constipation
Opioids
Cancer
Polyethylene glycol
Sennosides
Opioid Therapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.

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.

Primary outcomes:
measure: Bowel Performance Scale (BPS)
timeFrame: Last 18 days of each 21 day study period
Secondary outcomes:
measure: Patient Preference
timeFrame: end of study (6 weeks)
measure: Time (in Days) to Attain an Ideal BPS Score of Goal
timeFrame: 3 weeks (ascertained at the end of period 1)
measure: Incidence of Cramps
timeFrame: Last 18 days of each 21 day study period
measure: Rectal Measures
timeFrame: Last 18 days of each 21 day study period
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Philippa Hawley, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: