sing n-of-1 trials to determine the effectiveness of paracetamol in advancedcancer patients on opioids

Not Applicable

• Conditions: Cancer - Other cancer types; advanced cancer

• Registration Number: ACTRN12609000870257
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean VAS for average pain over the last 24 hours on days 2 and 3 of each cycle pair.[At the end of each pair of treatment periods]

Secondary Outcome Measures

Name	Time	Method
As for the primary endpoint, but using subscales of the Brief Pain Inventory (BPI) (worst pain, pain over last 24 hours, pain right now); Patient's Global Impression of Change (PGIC), changes in physical performance on the AKPS (Australian Karnofsky Performance Scale); changes in use of breakthrough pain relief; and frequency and type of paracetamol side effects.[a) Baseline: Age, sex, cancer diagnosis, duration and site of chronic pain, pre-trial analgesia (dose and frequency) and concomitant medications will be collected.<br>b) Daily self-recording of VAS, BPI, PGIC, any side effects, number of breakthrough medication doses, and any changes in baseline analgesia or concomitant analgesia. The staff will record AKPS at the end of each three day pair.<br>c) Patient guess of which drug they are taking after each 3 days, and their preferred medicine at the end of each cycle.<br>d) Compliance check: medication compliance and extent of diary completion at 18 days.]