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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.
 
ClinicalTrials.gov Identifier: NCT01189409
Recruitment Status : Terminated (This study was terminated based on results of interim analysis.)
First Posted : August 26, 2010
Results First Posted : October 19, 2018
Last Update Posted : August 28, 2019
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 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
Actual Primary Completion Date : December 2017
Actual Study Completion Date : October 2018


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 ]
    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 :
  1. Patient Preference [ Time Frame: 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).

  2. Time (in Days) to Attain an Ideal BPS Score of Goal [ Time Frame: 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.


  3. Incidence of Cramps [ Time Frame: Last 18 days of each 21 day study period ]
    The patients were asked to indicate any experience of cramps while on study treatment

  4. Rectal Measures [ Time Frame: 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



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT01189409


Locations
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Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Principal Investigator: Philippa Hawley, FRCPC British Columbia Cancer Agency
  Study Documents (Full-Text)

Documents provided by Pippa Hawley, British Columbia Cancer Agency:

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Responsible Party: Pippa Hawley, Principal Investigator, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01189409    
Other Study ID Numbers: H0901329
First Posted: August 26, 2010    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pippa Hawley, British Columbia Cancer Agency:
Constipation
Opioids
Cancer
Polyethylene glycol
Sennosides
Opioid Therapy
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Sennoside A&B
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cathartics
Gastrointestinal Agents