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
About this trial
This is an interventional treatment trial for Advanced Cancer focused on measuring Paracetamol, opioids, cancer pain
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.
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
NCT ID
NCT01313247
First Posted
March 10, 2011
Last Updated
March 10, 2011
Sponsor
Haraldsplass Deaconess Hospital
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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