Paracetamol for Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313247
Recruitment Status : Unknown
Verified March 2011 by Haraldsplass Deaconess Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2011
Last Update Posted : March 11, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Opioid Use, Unspecified Drug: paracetamol Drug: placebo tablets Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Placebo Comparator: Placebo pills
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
Drug: placebo tablets
Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
Other Name: Suger pills

Active Comparator: oral paracetamol 4 g daily
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Drug: paracetamol
1000 mg 4 times daily
Other Name: Acetaminophen

Primary Outcome Measures :
  1. Pain reduction caused by paracetamol 4g/d [ Time Frame: 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 :
  1. Overall satisfaction with the pain treatment [ Time Frame: End of each 3 days study period ]
    Total ESAS score Sweating during nighttime general wellbeing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313247

Contact: Jan Henrik Rosland, MD, PhD +4755979400 ext 79387
Contact: Sindre Hoel, MD +4755975000

Haraldsplass Deaconess Hospital Not yet recruiting
Bergen, Norway, 5009
Principal Investigator: Sindre Hoel, MD         
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
Principal Investigator: Jan Henrik Rosland, MD, PhD Haraldsplass Deaconess Hospital

Responsible Party: Jan Henrik Rosland, professor, Haraldsplass Deaconess Hospital Identifier: NCT01313247     History of Changes
Other Study ID Numbers: Par 06-0045
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: March 2011

Keywords provided by Haraldsplass Deaconess Hospital:
cancer pain

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs