Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control
NCT ID: NCT05088876
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2024-08-28
2026-07-31
Brief Summary
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Detailed Description
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Next to baseline the patients will be instructed to use a pain diary to rate their pain during the study and also document the required opioid rescue doses. Further assessments will include adverse events, subjective ratings of quality of sleep, overall feeling of functioning and quality of life. At the screening visit, patients will also be asked to rate their expected changes in pain relief as a result of co-treatment with paracetamol. At the completion of the study, patients will be asked about their preference and whether, overall, they felt their pain was more poorly controlled during the study.
Adherence will be checked by pill count and measurement of paracetamol blood concentrations. Genotyping of OPRM1, COMT and relevant CYP enzymes and opioid blood concentrations will be assessed as co-variates for pain control.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paracetamol
Paracetamol
Paracetamol in the dose already used
Placebo
Placebo
Blinded withdrawal of regular co-medication with paracetamol
Interventions
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Placebo
Blinded withdrawal of regular co-medication with paracetamol
Paracetamol
Paracetamol in the dose already used
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Swiss National Science Foundation
OTHER
Responsible Party
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Principal Investigators
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Evangelia Liakoni
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Bern University Hospital
Locations
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Kantonsspital Baden
Baden, , Switzerland
Inselspital, Bern University Hospital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Maria Wertli, Prof.
Role: primary
Other Identifiers
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BASEC-ID: 2021-01518
Identifier Type: -
Identifier Source: org_study_id
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