Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain

NCT02706769 | Terminated

• 1 other identifier: AC15006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Participants will take blinded Paracetamol (as they were taking before entering the study)

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Participants will take blinded Paracetamol

Drug: Placebo

Interventions

Placebo DRUG

Study medication contains blinded placebo

Placebo

Paracetamol DRUG

Study medication contains blinded paracetamol

Paracetamol

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Western General Hospital

Edinburgh, EH4 2XR, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: March 11, 2016
• Study Start: November 25, 2016
• Primary Completion: September 4, 2018
• Study Completion: May 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

GB (1)