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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by British Columbia Cancer Agency.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  1. Adult patient (18 years and above) with diagnosis of cancer.
  2. Patient has constipation defined as BPS (Bowel Performance Score) -2 or less.
  3. Patient is able to communicate effectively with staff.
  4. Expected prognosis more than 12 weeks.
  5. On opioid therapy with daily dose range no more than 30% of minimum daily consumption over previous 7 days.
  6. Patients may be included if they have previously been taking laxatives but are still constipated (BPS -2 or less).

Exclusion Criteria:

  1. Patient unable to take oral medication.
  2. 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.
  3. Allergy or previous intolerance to PEG or sennosides.
  4. Lactose intolerant.
  5. Contraindication to PEG or sennosides.
  6. Known or suspected bowel obstruction or ileus.
  7. Colostomy or ileostomy.
  8. Inflammatory bowel disease.
  9. Hospitalisation expected within the study period.
  10. Patient unable to complete the study diary in English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive
Senna Extract
Sennoside A&B
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014