PARASTOP - Paracetamol With Strong Opioids

Cancer Clinical Trial

— PARASTOP  

Official title:

PARASTOP - Paracetamol With Strong Opioids. A Randomized, Double-blind, Parallel-group Non-inferiority Phase III Withdrawal Trial of Paracetamol Versus Placebo in Conjunction With Opioids for Moderate to Severe Cancer-related Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051735
• Other study ID #: 180946
• Status: Recruiting
• Phase: Phase 3
• Start date: October 20, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Lise Torpen
• Phone: +4790864581
• Email: linyto[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 31, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Pain

Intervention

Drug:
• Paracetamol
Paracetamol 500 mg
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Norway	Helse Møre og Romsdal	Ålesund
Norway	Vestre Viken Hospital Trust	Drammen
Norway	Førde Hospital Trust	Førde
Norway	Sørlandet Hospital Trust	Kristiansand
Norway	Akershus University Hospital	Lørenskog
Norway	OsloUH	Oslo
Norway	Østfold Hospital Trust	Sarpsborg	Grålum
Norway	Telemark Hospital Trust	Skien
Norway	Stavanger University Hospital	Stavanger
Norway	Vestfold Hospital trust	Tønsberg
Norway	Universitetssykehuset Nord-Norge	Tromsø
Norway	St. Olavs Hospital	Trondheim
United Kingdom	Edinburgh Cancer Research	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sykehuset Telemark

Countries where clinical trial is conducted

Italy,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects.	Opioid Side Effects Questionnaire	7 days
Secondary	To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement.	Patient Global Impression of Change	7 days
Secondary	To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements.	Opioid consumption	7 days