Clinical trial · Interventional
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated based on results of interim analysis.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Constipation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG then Senna | Drug | — | UNRESOLVED |
| Senna then PEG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PEG then Senna
- description
- PEG in stepped bowel protocol
- interventionNames
- Drug: PEG then Senna
- type
- EXPERIMENTAL
- label
- Senna then PEG
- description
- Stepped bowel protocol with Senna then PEG
- interventionNames
- Drug: Senna then PEG
Primary outcomes (1)
- measure
- Bowel Performance Scale (BPS)
- timeFrame
- Last 18 days of each 21 day study period
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available