Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Paracetamol

• Registration Number: NCT02706769
• Lead Sponsor: University of Edinburgh

Brief Summary

National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Study Start: 2016-11-25
• Primary Completion: 2018-09-04
• Study Completion: 2019-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Age 16 years and over
2. Under palliative care/oncology service review
3. Diagnosis of incurable cancer
4. Clinician-predicted life expectancy >2 months
5. Anticipated to be clinically stable for duration of study involvement
6. Receiving daily regular strong opioids
7. Able to take study drug/placebo in its current form
8. Prescribed and taking paracetamol 1g four times a day
9. Average pain >3 and <9 in past 24 hours
10. Able to provide written informed consent
11. Able to complete necessary assessments required as part of the trial
12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation

Exclusion Criteria

1. Pain which the clinician deems to be unstable
2. Clinically significant renal or liver disease
3. Weight less than 50kg
4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
5. Co-enrolment in other drug trials
6. Known to be pregnant or breast-feeding at the time of recruitment
7. Previously enrolled in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will take blinded Paracetamol
Paracetamol	Paracetamol	Participants will take blinded Paracetamol (as they were taking before entering the study)

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.	14 days

Trial Locations

Locations (1)

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom