Paracetamol for Cancer Pain

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01313247
• Other study ID #: Par 06-0045
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 10, 2011
• Last updated: March 10, 2011
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2011
• Source: Haraldsplass Deaconess Hospital
• Contact: Jan Henrik Rosland, MD, PhD
• Phone: +4755979400
• Email: jhro[@]haraldsplass.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Opioid Use, Unspecified

Intervention

Drug:
• paracetamol
1000 mg 4 times daily
• placebo tablets
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Overall satisfaction with the pain treatment	Total ESAS score Sweating during nighttime general wellbeing	End of each 3 days study period	No