PARASTOP - Paracetamol with Strong Opioids in Moderate to Severe Cancer Pain
Research type
Research Study
Full title
PARASTOP - Paracetamol with Strong Opioids - A randomized, double-blind, parallel-group non-inferiority phase III withdrawal trial of paracetamol versus placebo in conjunction with opioids for moderate to severe cancer-related pain
IRAS ID
1004755
Contact name
Lise Nylund Torpen
Contact email
Sponsor organisation
Oslo University Hospital
Eudract number
2020-005123-36
Clinicaltrials.gov Identifier
Research summary
National guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong opioid pain killers. Although studies show this is beneficial in other conditions, (such as dental problems or after surgery), taking paracetamol has not been shown to further improve pain in patients with cancer-related pain who are using opioids. Taking paracetamol may cause side effects, especially liver damage. As many people find taking tablets burdensome the aim of this study is to show whether strong painkillers (opioids such as morphine) provide approximately the same pain relief when given alone without paracetamol. If so, patients can stop taking paracetamol. Patients using both palliative care and oncology in-patient and out-patient services will be invited to take part in the study. Eligible participants will be adults with a diagnosis of metastatic cancer currently taking full dose paracetamol (1 gram four times a day) and a strong opioid pain killer who still have some pain. Study participants will be randomly allocated to receive either paracetamol or an identical ‘dummy tablet’ (placebo) for 8 days. Neither the participant, their doctor or other researchers will know whether the participant is taking placebo or paracetamol. Participants will have access to other pain killers “on demand” to secure sufficient pain relief throughout the study period. Participants will be asked to record their pain scores, opioid pain killer use and any side effects every day for a week in a diary. Assessments at the start and end of the study will be in person. Blood samples for analyses of paracetamol and level of strong opioids will be collected at the in person assessments (day 1 and day 8). Participants will receive one telephone follow-up call after day 8. The total trial duration for each participant will be a maximum of 14 days.
REC name
West of Scotland REC 1
REC reference
22/WS/0052
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion