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Cancer pain study questions need for extra paracetamol pills

NCT ID NCT05051735

Symptom relief Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether cancer patients already taking strong opioids like morphine can stop taking paracetamol without their pain getting worse. 204 adults with metastatic cancer and stable pain on both medications were randomly assigned to continue paracetamol or switch to a placebo. The goal was to see if dropping paracetamol is just as good for pain control, potentially reducing the burden of taking many pills each day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paracetamol (acetaminophen)
What this could lead to
If stopping paracetamol proves non-inferior, patients could take fewer pills daily without worsening pain, reducing pill burden.
What could go wrong
The trial is completed but results are not yet reported. Even if non-inferior, individual responses may vary, and some patients might need paracetamol for optimal pain control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

204 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be ≥ 18 years of age inclusive, at the time of signing the informed consent. * ≥50 kg (due to paracetamol dosage) * Participants who are under palliative care or oncology service review * Diagnosis of metastatic cancer * Clinician-predicted life expectancy \>2 months * Receiving daily regular strong opioids for cancer pain * Receiving stable scheduled opioid dose last 48 hours\* * Receiving paracetamol 1 gram x three or four times a day for at least five days * Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)\* * Able to take study drug/placebo as tablets * Able to comply with all study procedures * Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * It is allowed to repeat procedure within the screening period without considering the participant being a rescreen Exclusion Criteria: * History of allergy or hypersensitivity to any of the active substances or excipients in the study drug * Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4\* precluding continuation of paracetamol. (\*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) * Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy * Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment * Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies) * Previously enrolled in this study * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

cancer Cancer Pain metastatic malignant neoplasm neoplasm Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Cancer pain

Contacts and locations

Locations

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Edinburgh Cancer Research

    Edinburgh, United Kingdom

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Førde Hospital Trust

    Førde, Førde, 6812, Norway

  • Helse Møre og Romsdal

    Ålesund, 6026, Norway

  • Makere University Hospital

    Kampala, Uganda

  • OsloUH

    Oslo, 0424, Norway

  • St. Olavs Hospital

    Trondheim, 7030, Norway

  • Stavanger University Hospital

    Stavanger, Stavanger, 4011, Norway

  • Sørlandet Hospital Trust

    Kristiansand, Kristiansand, 4604, Norway

  • Telemark Hospital Trust

    Skien, Norway

  • Universitetssykehuset Nord-Norge

    Tromsø, 9019, Norway

  • Vestfold Hospital trust

    Tønsberg, 3103, Norway

  • Vestre Viken Hospital Trust

    Drammen, Drammen, 3004, Norway

  • Østfold Hospital Trust

    Sarpsborg, Grålum, 1714, Norway

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