NCT05051735

Brief Summary

Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified. The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2021

Typical duration for phase_3

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

September 11, 2021

Last Update Submit

February 23, 2026

Conditions

CancerCancer Pain

Keywords

Cancer PainPainAnalgesicsSensory System AgentsPhysiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

  • To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer-related pain.

    Numeric Rating Scale 0-10: Average pain intensity past 24 hours

    7 days

Secondary Outcomes (3)

  • To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects.

    7 days

  • To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement.

    7 days

  • To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements.

    7 days

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol P.O. 500 mg 2 tablets four times a day for 7 days

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Placebo P.O. 2 tablets four times a day for 7 days

Drug: Placebo

Interventions

ParacetamolDRUG

Paracetamol 500 mg

Also known as: Acetaminophen
Paracetamol
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Vestre Viken Hospital Trust

Drammen, Drammen, 3004, Norway

Location

Førde Hospital Trust

Førde, Førde, 6812, Norway

Location

Østfold Hospital Trust

Sarpsborg, Grålum, 1714, Norway

Location

Sørlandet Hospital Trust

Kristiansand, Kristiansand, 4604, Norway

Location

Stavanger University Hospital

Stavanger, Stavanger, 4011, Norway

Location

Helse Møre og Romsdal

Ålesund, 6026, Norway

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

OsloUH

Oslo, 0424, Norway

Location

Telemark Hospital Trust

Skien, Norway

Location

Universitetssykehuset Nord-Norge

Tromsø, 9019, Norway

Location

St. Olavs Hospital

Trondheim, 7030, Norway

Location

Vestfold Hospital trust

Tønsberg, 3103, Norway

Location

Makere University Hospital

Kampala, Uganda

Location

Edinburgh Cancer Research

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Cancer PainNeoplasmsPain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ørnulf Paulsen

    Telemark Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 21, 2021

Study Start

October 20, 2021

Primary Completion

February 11, 2026

Study Completion

February 18, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

NO(12)UG(1)GB(1)IT(1)