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PARASTOP - Paracetamol With Strong Opioids (PARASTOP)

Primary Purpose

Cancer Pain, Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring Cancer Pain, Pain, Analgesics, Sensory System Agents, Physiological Effects of Drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Østfold Hospital TrustRecruiting
  • Vestre Viken Hospital TrustRecruiting
  • Førde Hospital TrustRecruiting
  • Sørlandet Hospital TrustRecruiting
  • Akershus University HospitalRecruiting
  • OsloUHRecruiting
  • Telemark Hospital TrustRecruiting
  • Stavanger University HospitalRecruiting
  • Universitetssykehuset Nord-NorgeRecruiting
  • St. Olavs HospitalRecruiting
  • Vestfold Hospital trust
  • Helse Møre og RomsdalRecruiting
  • Edinburgh Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paracetamol

Placebo

Arm Description

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

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

Outcomes

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.
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.
Opioid Side Effects Questionnaire
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement.
Patient Global Impression of Change
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements.
Opioid consumption

Full Information

First Posted
September 11, 2021
Last Updated
February 23, 2023
Sponsor
Oslo University Hospital
Collaborators
Sykehuset Telemark
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1. Study Identification

Unique Protocol Identification Number
NCT05051735
Brief Title
PARASTOP - Paracetamol With Strong Opioids
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sykehuset Telemark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Cancer
Keywords
Cancer Pain, Pain, Analgesics, Sensory System Agents, Physiological Effects of Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Paracetamol P.O. 500 mg 2 tablets four times a day for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo P.O. 2 tablets four times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Description
Paracetamol 500 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer-related pain.
Description
Numeric Rating Scale 0-10: Average pain intensity past 24 hours
Time Frame
7 days
Secondary Outcome Measure Information:
Title
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects.
Description
Opioid Side Effects Questionnaire
Time Frame
7 days
Title
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement.
Description
Patient Global Impression of Change
Time Frame
7 days
Title
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements.
Description
Opioid consumption
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Torpen
Phone
+4790864581
Email
linyto@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Siv Åshild Billington
Phone
+4797777857
Email
sivwii@sthf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ørnulf Paulsen
Organizational Affiliation
Telemark Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Individual Site Status
Terminated
Facility Name
Østfold Hospital Trust
City
Sarpsborg
State/Province
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Steffen
First Name & Middle Initial & Last Name & Degree
Michael Steffen
Facility Name
Vestre Viken Hospital Trust
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Moksnes Husby
First Name & Middle Initial & Last Name & Degree
Kristin Moksnes Husby
Facility Name
Førde Hospital Trust
City
Førde
ZIP/Postal Code
6812
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helge Sårheim
First Name & Middle Initial & Last Name & Degree
Helge Sårheim
Facility Name
Sørlandet Hospital Trust
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marthe Cameron
First Name & Middle Initial & Last Name & Degree
Marthe Cameron
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Fredheim
First Name & Middle Initial & Last Name & Degree
Olav Fredheim
Facility Name
OsloUH
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Torpen
First Name & Middle Initial & Last Name & Degree
Katarina Rønning Hagen
Facility Name
Telemark Hospital Trust
City
Skien
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ørnulf Paulsen
First Name & Middle Initial & Last Name & Degree
Ørnulf Paulsen
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birthe Lie Hauge
First Name & Middle Initial & Last Name & Degree
Birthe Lie Hauge
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigve Andersen
First Name & Middle Initial & Last Name & Degree
Sigve Andersen
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Torbjørn Løhre
First Name & Middle Initial & Last Name & Degree
Erik Torbjørn Løhre
Facility Name
Vestfold Hospital trust
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Terminated
Facility Name
Helse Møre og Romsdal
City
Ålesund
ZIP/Postal Code
6026
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Åsmund Lund
First Name & Middle Initial & Last Name & Degree
Jo Åsmund Lund
Facility Name
Edinburgh Cancer Research
City
Edinburgh
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Fallon
First Name & Middle Initial & Last Name & Degree
Marie Fallon

12. IPD Sharing Statement

Learn more about this trial

PARASTOP - Paracetamol With Strong Opioids

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