Paracetamol for Cancer Pain

Phase 4

• Conditions: Advanced Cancer; Opioid Use, Unspecified
• Interventions: Drug: placebo tablets; Drug: paracetamol

• Registration Number: NCT01313247
• Lead Sponsor: Haraldsplass Deaconess Hospital

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.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-10
• Last Update Submitted: 2011-03-10
• Study First Posted: 2011-03-11
• Last Update Posted: 2011-03-11
• Study Start: 2011-04
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo pills	placebo tablets	Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
oral paracetamol 4 g daily	paracetamol	Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily

Primary Outcome Measures

Name	Time	Method
Pain reduction caused by paracetamol 4g/d	Last day in each 3 days study period	Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction with the pain treatment	End of each 3 days study period	Total ESAS score Sweating during nighttime general wellbeing

Trial Locations

Locations (1)

Haraldsplass Deaconess Hospital; 🇳🇴 Bergen, Norway