Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-25

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

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

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Study medication contains blinded paracetamol

Placebo

Participants will take blinded Paracetamol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Study medication contains blinded placebo

Interventions

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Placebo

Study medication contains blinded placebo

Intervention Type DRUG

Paracetamol

Study medication contains blinded paracetamol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No