Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
This study is currently recruiting participants.
Verified June 2011 by British Columbia Cancer Agency
Sponsor:
British Columbia Cancer Agency
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01189409
First received: March 17, 2010
Last updated: June 22, 2011
Last verified: June 2011
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Purpose
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 BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation Cancer |
Drug: PEG then Senna Drug: Senna then PEG |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by British Columbia Cancer Agency:
Primary Outcome Measures:
- Bowel Performance Scale (BPS) [ Time Frame: Last 18 days of each 21 day study period ] [ Designated as safety issue: No ]The proportion of days in which the BPS is within the range -1 to +1 wll be compared between treatment periods
Secondary Outcome Measures:
- Patient preference [ Time Frame: end of study (6 weeks) ] [ Designated as safety issue: No ]The patients will be asked to state which treament period they prefer
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PEG then Senna
PEG in stepped bowel protocol
|
Drug: 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).
Other Name: Lax-a-Day
|
|
Experimental: Senna then PEG
Stepped bowel protocol with Senna then PEG
|
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).
|
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 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patient (18 years and above) with diagnosis of cancer.
- Patient has constipation defined as BPS (Bowel Performance Score) -2 or less.
- Patient is able to communicate effectively with staff.
- Expected prognosis more than 12 weeks.
- On opioid therapy with daily dose range no more than 30% of minimum daily consumption over previous 7 days.
- Patients may be included if they have previously been taking laxatives but are still constipated (BPS -2 or less).
Exclusion Criteria:
- Patient unable to take oral medication.
- New treatment expected to affect bowel function during the study (6 weeks), e.g. opioid rotation, commencement of drug with laxative/constipating effect, such as misoprostol, ondansetron etc.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189409
Contacts
| Contact: Philippa Hawley, FRCPC | 604-866-6000 ext 2707 | phawley@bccancer.bc.ca |
| Contact: Brenda Ng | 604-866-6000 ext 2707 | bng@bccancer.bc.ca |
Locations
| Canada, British Columbia | |
| BC Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: P Hawley, B.Med FRCPC 604-877-6000 ext 2707 phawley@bccancer.bc.ca | |
| Principal Investigator: Philippa Hawley, FRCPC | |
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
| Principal Investigator: | Philippa Hawley, FRCPC | British Columbia Cancer Agency |
More Information
No publications provided
| Responsible Party: | Philippa Hawley, British Columbia Cancer Agency |
| ClinicalTrials.gov Identifier: | NCT01189409 History of Changes |
| Other Study ID Numbers: | H0901329 |
| Study First Received: | March 17, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by British Columbia Cancer Agency:
|
Constipation Opioids Cancer |
Polyethylene glycol Sennosides Opioid Therapy |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Senna Extract Sennoside A&B Analgesics, Opioid Cathartics Gastrointestinal Agents |
Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 22, 2013