Paracetamol for Cancer Pain

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01313247

Enrollment

Registered

2011-03-11

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Opioid Use, Unspecified

Keywords

Paracetamol, opioids, cancer pain

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.

Interventions

DRUGparacetamol

1000 mg 4 times daily

DRUGplacebo tablets

Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Norway

Contacts

Primary ContactJan Henrik Rosland, MD, PhD

jhro@haraldsplass.no+4755979400

Backup ContactSindre Hoel, MD

sindre.hoel@gmail.com+4755975000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026