PARASTOP - Paracetamol With Strong Opioids

Inclusion Criteria:

• Participants must be ≥ 18 years of age inclusive, at the time of signing theinformed 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 includescompliance with the requirements and restrictions listed in the informed consentform (ICF) and in this protocol.

• It is allowed to repeat procedure within the screening period withoutconsidering the participant being a rescreen

Exclusion Criteria:

• History of allergy or hypersensitivity to any of the active substances or excipientsin the study drug

• Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precludingcontinuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)

• Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioidtherapy

• Participants receiving systemic anticancer treatment during the intervention periodif they are anticipated to have increasing pain or other symptoms related to thetreatment

• Co-enrolment in other drug trials. Participants will not be enrolled in any otheron-going interventional clinical trial. Study participants may be enrolled innon-interventional research (e.g. questionnaire, tissue collection studies)

• Previously enrolled in this study

• Pregnant or lactating women