Paracetamol for Cancer Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Advanced Cancer, Opioid Use, Unspecified

Intervention / Treatment
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* Drug: paracetamol
* Drug: placebo tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pills<br>Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily | Drug: placebo tablets<br>* Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol<br>* Other names: Suger pills;|
| Active Comparator: oral paracetamol 4 g daily<br>Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily | Drug: paracetamol<br>* 1000 mg 4 times daily<br>* Other names: Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with the pain treatment | Total ESAS score Sweating during nighttime general wellbeing | End of each 3 days study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, opioids, cancer pain