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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01189409
Recruitment Status : Suspended (This study has been suspended because of staffing issues and pending review.)
First Posted : August 26, 2010
Last Update Posted : December 26, 2017
Information provided by (Responsible Party):
Pippa Hawley, 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.

Condition or disease Intervention/treatment Phase
Constipation Cancer Drug: PEG then Senna Drug: Senna then PEG Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind using a dummy alternate treatment.
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
Study Start Date : June 2010
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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).
Other Name: senokot

Primary Outcome Measures :
  1. Bowel Performance Scale (BPS) [ Time Frame: Last 18 days of each 21 day study period ]
    The proportion of days in which the BPS is within the range -1 to +1 wll be compared between treatment periods

Secondary Outcome Measures :
  1. Patient preference [ Time Frame: end of study (6 weeks) ]
    The patients will be asked to state which treament period they prefer

  2. Time (in days) to attain an ideal BPS score of Goal (patient's goal) [ Time Frame: 3 weeks (ascertained at the end of period 1) ]
    The time will be evaluated from Day 4 onward, since the first 3 days will be part of the washout period.

  3. rectal measures and incidence of cramps [ Time Frame: last 18 days of each study period ]
    The patients will be asked to indicate suppository use and experience of cramps while on study treatment

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01189409

Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Principal Investigator: Philippa Hawley, FRCPC British Columbia Cancer Agency

Responsible Party: Pippa Hawley, Principal Investigator, British Columbia Cancer Agency Identifier: NCT01189409     History of Changes
Other Study ID Numbers: H0901329
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pippa Hawley, British Columbia Cancer Agency:
Polyethylene glycol
Opioid Therapy

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Sennoside A&B
Senna Extract
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents