Advanced Cancer | Paracetamol for Cancer Pain
Advanced Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Opioid Use, Unspecified
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:paracetamol1000 mg 4 times daily
Drug:placebo tabletsPlacebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo pillsPlacebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
oral paracetamol 4 g dailyPatients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Start Date: April 2011
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Pain reduction caused by paracetamol 4g/d
Secondary Outcome: Overall satisfaction with the pain treatment
Study sponsors, principal investigator, and references
Principal Investigator: Jan Henrik Rosland, MD, PhD
Lead Sponsor: Haraldsplass Deaconess Hospital