Adult patients with metastatic cancer disease, cancer-related pain treated with regular strong opioids, receiving paracetamol (1 gram three or four times a day) and with average pain intensity past 24 hours of 2-7 (Numeric Rating Scale, NRS, 0-10) are eligible.
Conditions
Interventions
Trade Name: Paracet
Product Name: Paracet
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be = 18 years of age inclusive, at the time of signing the informed consent. 2. =50 kg (due to paracetamol dosage) 3. Participants who are under palliative care or oncology service review 4. Diagnosis of metastatic cancer 5. Clinician-predicted life expectancy >2 months 6. Receiving daily regular strong opioids for cancer pain 7. Receiving stable scheduled opioid dose last 48 hours 8. Receiving paracetamol 1 gram x three or four times a day for at least five days 9. Average pain intensity past 24 hours = 2 and = 7 (NRS 0-10) 10. Able to take study drug/placebo as tablets 11. Able to comply with all study procedures 12. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
Exclusion criteria: 1. History of allergy or hypersensitivity to any of the active substances or excipients in the study drug 2. 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) 3. Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy 4. Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment 5. 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) 6. Previously enrolled in this study 7. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate whether withdrawal of paracetamol when used together with strong opioids provides inferior pain control compared to continuous use of paracetamol together with strong opioids. ;Secondary Objective: - Does placebo compared to paracetamol in cancer pain patients already on strong opioids result in more opioid-related side effects? - Does paracetamol withdrawal in cancer pain patients already on strong opioids influence patient’s global impression of change? - Does placebo compared to paracetamol in patients with cancer-related pain already on strong opioids change patients’ opioid consumption?;Primary end point(s): Average pain intensity;Timepoint(s) of evaluation of this end point: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Patient reported opioid related side effects - Patient global impression of change (PGIC) (6) - Opioid consumption Day 8 (Total amount of scheduled and on demand opioids);Timepoint(s) of evaluation of this end point: Day 8 | — |
Countries
Italy, Norway, United Kingdom
Contacts
Public ContactNational coordinating investigator
Telemark Hospital Trust
Outcome results
None listed