Using paracetamol with opioids for chronic cancer pain management
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study
PHASE4 · Insel Gruppe AG, University Hospital Bern · NCT05088876
This study is testing if taking paracetamol with strong painkillers can help people with chronic cancer pain feel better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 2 sites (Baden and 1 other locations) |
| Trial ID | NCT05088876 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of paracetamol when used alongside strong opioids in patients with chronic cancer pain. Participants will be randomly assigned to receive either their prescribed dose of paracetamol or a placebo for the first week, followed by a withdrawal phase where both groups will stop taking paracetamol or placebo. Throughout the study, patients will maintain a pain diary to track their pain levels and any required opioid rescue doses. Additional assessments will include quality of sleep, overall functioning, and quality of life, with adherence monitored through pill counts and blood tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently receiving a WHO step III opioid in combination with paracetamol.
Not a fit: Patients who have recently changed their analgesic treatment or participated in another interventional trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management strategies for patients with chronic cancer pain.
How similar studies have performed: Previous studies have explored the use of paracetamol in pain management, but this specific combination with strong opioids in chronic cancer pain is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day) * Age ≥ 18 at screening * Ability to understand the study procedures and to provide written informed consent * Stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days Exclusion Criteria: * Participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials * Changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyrone), within the last 7 days preceding randomisation * Surgery within the 14 days preceding randomisation or surgery planned within the duration of the study * Any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol
Where this trial is running
Baden and 1 other locations
- Kantonsspital Baden — Baden, Switzerland (RECRUITING)
- Inselspital, Bern University Hospital — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Evangelia Liakoni — Inselspital, Bern University Hospital
- Study coordinator: Evangelia Liakoni
- Email: evangelia.liakoni@insel.ch
- Phone: 0041316325461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain