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Paracetamol for Cancer Pain

Primary Purpose

Advanced Cancer, Opioid Use, Unspecified

Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
paracetamol
placebo tablets
Sponsored by
Haraldsplass Deaconess Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring Paracetamol, opioids, cancer pain

Eligibility Criteria

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

Inclusion Criteria:

  • Adults (> 18 years) of both sexes
  • Diagnosed with advanced cancer disease
  • Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
  • NRS median pain score last 24 hrs > 4
  • Able to take tablets (paracetamol) orally

Exclusion Criteria:

  • Mental or physical deficiency precluding data collection.
  • Reduced liver function judged with bilirubin, INR and transaminases
  • Anticoagulation with warfarin
  • Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
  • Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.

Sites / Locations

  • Haraldsplass Deaconess Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo pills

oral paracetamol 4 g daily

Arm Description

Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily

Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily

Outcomes

Primary Outcome Measures

Pain reduction caused by paracetamol 4g/d
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.

Secondary Outcome Measures

Overall satisfaction with the pain treatment
Total ESAS score Sweating during nighttime general wellbeing

Full Information

First Posted
March 10, 2011
Last Updated
March 10, 2011
Sponsor
Haraldsplass Deaconess Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01313247
Brief Title
Paracetamol for Cancer Pain
Official Title
Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Haraldsplass Deaconess Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomised, double-blind placebo controlled cross-over trial Main goal: Optimize the medical pain treatment for patients with advanced cancer disease Study goal: Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
Detailed Description
National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief. Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover. Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Opioid Use, Unspecified
Keywords
Paracetamol, opioids, cancer pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo pills
Arm Type
Placebo Comparator
Arm Description
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
Arm Title
oral paracetamol 4 g daily
Arm Type
Active Comparator
Arm Description
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Description
1000 mg 4 times daily
Intervention Type
Drug
Intervention Name(s)
placebo tablets
Other Intervention Name(s)
Suger pills
Intervention Description
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Primary Outcome Measure Information:
Title
Pain reduction caused by paracetamol 4g/d
Description
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Time Frame
Last day in each 3 days study period
Secondary Outcome Measure Information:
Title
Overall satisfaction with the pain treatment
Description
Total ESAS score Sweating during nighttime general wellbeing
Time Frame
End of each 3 days study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (> 18 years) of both sexes Diagnosed with advanced cancer disease Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily NRS median pain score last 24 hrs > 4 Able to take tablets (paracetamol) orally Exclusion Criteria: Mental or physical deficiency precluding data collection. Reduced liver function judged with bilirubin, INR and transaminases Anticoagulation with warfarin Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Henrik Rosland, MD, PhD
Phone
+4755979400
Ext
79387
Email
jhro@haraldsplass.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sindre Hoel, MD
Phone
+4755975000
Email
sindre.hoel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Henrik Rosland, MD, PhD
Organizational Affiliation
Haraldsplass Deaconess Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haraldsplass Deaconess Hospital
City
Bergen
ZIP/Postal Code
5009
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sindre Hoel, MD

12. IPD Sharing Statement

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Paracetamol for Cancer Pain

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