PARASTOP - Paracetamol With Strong Opioids

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05051735

Collaborator

Sykehuset Telemark (Other)

204

Enrollment

Locations

Arms

38.4

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Pain Cancer	Drug: Paracetamol Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paracetamol Paracetamol P.O. 500 mg 2 tablets four times a day for 7 days	Drug: Paracetamol Paracetamol 500 mg Other Names: Acetaminophen
Placebo Comparator: Placebo Placebo P.O. 2 tablets four times a day for 7 days	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Paracetamol

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

Drug: Paracetamol

Paracetamol 500 mg

Other Names:

Acetaminophen

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer-related pain. [7 days]
Numeric Rating Scale 0-10: Average pain intensity past 24 hours

Secondary Outcome Measures

To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects. [7 days]
Opioid Side Effects Questionnaire
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement. [7 days]
Patient Global Impression of Change
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements. [7 days]
Opioid consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	Italy
2	Vestre Viken Hospital Trust	Drammen	Norway	3004
3	Førde Hospital Trust	Førde	Norway	6812
4	Sørlandet Hospital Trust	Kristiansand	Norway	4604
5	Akershus University Hospital	Lørenskog	Norway	1478
6	OsloUH	Oslo	Norway	0424
7	Telemark Hospital Trust	Skien	Norway
8	Universitetssykehuset Nord-Norge	Tromsø	Norway	9019
9	St. Olavs Hospital	Trondheim	Norway	7030
10	Vestfold Hospital trust	Tønsberg	Norway	3103
11	Helse Møre og Romsdal	Ålesund	Norway	6026
12	Edinburgh Cancer Research	Edinburgh	United Kingdom