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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189409
• Other study ID #: H0901329
• Status: Terminated
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: October 2018

Study information

• Verified date: August 2019
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: October 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Constipation

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Performance Scale (BPS)	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.	Last 18 days of each 21 day study period
Secondary	Patient Preference	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).	end of study (6 weeks)
Secondary	Time (in Days) to Attain an Ideal BPS Score of Goal	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 weeks (ascertained at the end of period 1)
Secondary	Incidence of Cramps	The patients were asked to indicate any experience of cramps while on study treatment	Last 18 days of each 21 day study period
Secondary	Rectal Measures	The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment	Last 18 days of each 21 day study period