Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control

Last updated: March 3, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

4

Condition

Cancer Pain

Acute Pain

Chronic Pain

Treatment

Paracetamol

Placebo

Clinical Study ID

NCT05088876
BASEC-ID: 2021-01518
  • Ages > 18
  • All Genders

Study Summary

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients receiving a WHO step III opioid (i.e. morphine, oxycodone,methadone, fentanyl, hydromorphone, or buprenorphine) in combination withparacetamol (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 theanalgesic treatment during the previous 7 days

Exclusion

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. tricyclicantidepressants, 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 theduration of the study

  • Any circumstances, comorbidities or conditions, which, in the opinion of theinvestigator, may affect full participation in the study or compliance with thestudy protocol

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Paracetamol
Phase: 4
Study Start date:
August 28, 2024
Estimated Completion Date:
July 31, 2026

Study Description

Chronic pain patients receiving a strong opioid in combination with paracetamol in a minimum dose of 1.5 g/day will be randomized to receive either paracetamol in the dose already prescribed (group "paracetamol") or an identically looking placebo (group "placebo") using the same schedule during the first study phase (days 1-7). In the second study phase (days 8-14) paracetamol or placebo will be stopped in both arms to assess the effect of pill withdrawal on pain control.

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.

Connect with a study center

  • Kantonsspital Baden

    Baden,
    Switzerland

    Active - Recruiting

  • St. Claraspital AG

    Basel,
    Switzerland

    Site Not Available

  • Inselspital, Bern University Hospital

    Bern,
    Switzerland

    Active - Recruiting

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