PARASTOP - Paracetamol With Strong Opioids

Launched by OSLO UNIVERSITY HOSPITAL · Sep 20, 2021

Keywords

ClinConnect Summary

The PARASTOP clinical trial is studying whether it is necessary for cancer patients to continue taking paracetamol (a common pain reliever) when they are already using strong pain medications like morphine. The goal is to see if stopping paracetamol affects pain control for those already on these stronger painkillers. This study is important because current guidelines suggest that all cancer patients should take paracetamol alongside their opioids, even though it's unclear if this really helps with cancer-related pain. By determining if stopping paracetamol makes a difference, the researchers hope to reduce the burden on patients who have to take extra tablets daily.

To be eligible for this study, participants must be at least 18 years old and have metastatic cancer (cancer that has spread to other parts of the body). They should also be receiving strong opioid pain medication and have been taking paracetamol regularly. Participants will be asked to take either paracetamol or a placebo (a pill with no active ingredient) and will be monitored for their pain levels. It's crucial for potential participants to know that they will need to meet specific health criteria and that the study requires their commitment to follow the procedures outlined.

Gender

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Eligibility criteria

• 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