None listed
Conditions
Brief summary
This study aims to determine the effectiveness of paracetamol for treating pain relief in people with advanced cancer who are currently taking opioids. Who is it for? You can join this study if you have advanced cancer with chronic cancer-related pain and you are currently taking opioids to control the pain. Trial details Participants will either start treatment with paracetamol in addition to regular opioids or they will start treatment with a non-active compound (*placebo) plus regular opioids. Participants will then cross-over to receive either placebo (if they started by tak! ing paracetamol) or to receive paracetamol (if they started by taking a placebo). Participants will undergo 3 pairs of 3 day treatments (cycles), making a total of 18 days. The drugs being used are paracetamol 500 mg, and placebo, orally, two capsules three times daily. Participants complete a daily diary recording pain scores, side effects, which treatment they prefer, and their estimate of which drug they are taking at the time. The study aims to determine the efficacy of paracetamol in alleviating pain in patients with advanced cancer who are taking routine opioids. It will also allow an evaluation of the study techniques (n-of-1 trial design which is when one patient is randomised from one treatment and then to another to allow comparison) and development of appropriate statistical techniques for the analysis of trial data, and where appropriate, provide a means of adjusting for illness progression.
Interventions
The patient will undergo 3 pairs of 3 day treatments (cycles), making a total of 18 days. The order of drugs in each cycle will be determined by random allocation, blinded to both clinician and patient. Patients complete a daily diary recording pain scores, side effects, which treatment they prefer, and their estimate of which drug they are taking at the time. Data from days 2 and 3 will be used for analysis of that cycle to allow for washout (so day 1 is use das a washout). The drugs being used
The patient will undergo 3 pairs of 3 day treatments (cycles), making a total of 18 days. The order of drugs in each cycle will be determined by random allocation, blinded to both clinician and patient. Patients complete a daily diary recording pain scores, side effects, which treatment they prefer, and their estimate of which drug they are taking at the time. Data from days 2 and 3 will be used for analysis of that cycle to allow for washout (so day 1 is use das a washout). The drugs being used are long-acting paracetamol 665 mg, and placebo, orally, two capsules three times daily. At the end of the trial, the order of medications is unmasked, and compared with the patient’s observations. Repeated results in the same direction favouring the treatment can be reported in terms of a probability that the result is true. The clinical importance of the result is described by comparing it to a predetermined clinically important change.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged >18 years, with: 1) a clinical diagnosis of chronic cancer-related pain (predominantly nocioceptive rather than neuropathic in origin, Leeds Assessment of Neuropathic Symptoms and Signs (LANNS) score (27) <12), with a Brief Pain Inventory (BPI) (28) average pain score of = 3; 2) a stable baseline dose of opioid (excluding codeine or tramadol) with no more than 2 breakthrough doses of opioid per day. The opioid dose will have been stable for at least 5 days prior to commencing the trial; 3) a stable dose of other regular medications for at least five days before the trial commences. Patients already on paracetamol are eligible, but must stop paracetamol 3 days before the trial; 4) no intervention eg radiotherapy, chemotherapy, surgery that might alter pain levels during the 2 weeks prior to the study period or plans to undergo such during the study period. 5) an intact small bowel (necessary for absorption of extended release preparations), no bowel obstruction 6) satisfactory liver function (Aspartate transaminase (AST), Alanine aminotransferase (ALT) = 1.5x upper limit of normal, total bilirubin within normal range); 7) no known allergy or sensitivity to paracetamol; 8) ability to give fully informed written consent and complete daily pain diaries.
Exclusion criteria
Patients with: 1) an alcohol intake of >3 units/day; 2) cognitive impairment that in the clinician’s opinion would preclude fully informed consent or ability to complete study requirements; 3) a poor understanding of written English; 4) life expectancy less than 6 weeks.
Outcome results
None listed