Acetaminophen for Cancer Pain - Full Text View

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152854

Purpose

Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients demonstrated better pain control without an increase in side effects. This study will determine if regular acetaminophen improves pain control when added to strong opioids in patients with cancer pain.

Condition	Intervention	Phase
Cancer Pain	Drug: Acetaminophen Drug: acetaminophen Drug: placebo, sugar pill	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomised, Placebo-Controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Patient preference for the acetaminophen or the placebo arm as assessed by asking the patient whether he/she preferred treatment period 1 or treatment period 2 [ Time Frame: Post completion of period 2 ] [ Designated as safety issue: No ]
Differences in the mean pain intensity score as assessed by the daily average Numeric Rating Scale (NRS) pain score during the week given acetaminophen compared with the daily average NRS pain score during the week given placebo [ Time Frame: post period 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting) [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
drowsiness [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
constipation [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
cold sweats [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
overall sense of well being [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Total analgesic consumption in each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Best and worst pain scores for each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Pain relief obtained in each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Effect of pain on functional ability [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Strength of preference for acetaminophen versus placebo on a 5-point scale [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
Proportion of patients having a clinically significant improvement in pain (defined as an improvement in mean NRS of at least 33% during the week taking acetaminophen) [ Time Frame: post period 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1, acetaminophen: Active Comparator acetaminophen	Drug: Acetaminophen acetaminophen 1g po qid Drug: acetaminophen acetaminophen 1g po qid for 7 days
B placebo: Placebo Comparator placebo PO qid	Drug: placebo, sugar pill

Detailed Description:

Aim:

To assess whether regular oral acetaminophen can reduce pain in cancer patients already on a strong opioid regimen.

Rationale:

It is estimated that 75% of people with advanced cancer suffer significant pain. Many of these people continue to have pain despite being on strong opioids. The rationale behind adding an additional analgesic with a different mechanism of action is to attempt to improve analgesia without increasing side effects.

Overview:

This is a double blind, randomised placebo-controlled, crossover trial to evaluate whether the addition of regular acetaminophen can reduce pain in cancer patients already on a strong opioid regimen. The study will be performed in ambulatory cancer patients who have pain that is believed to be caused by their cancer, and who have already been stabilised on an opioid regimen of > 60mg/day of morphine equivalents. Each patient will be randomly allocated to receive either acetaminophen 1g qid or an identical appearing placebo qid for a seven-day period, and then crossed over to the other arm for a further seven-day period. Patients will complete daily pain diaries and weekly questionnaires (Brief Pain Inventory) and comparison will be made between the pain scores for the two treatment periods. Patient preference for the two treatment periods will also be evaluated.

Research Question:

A randomised, double-blind, placebo controlled crossover trial to determine if the addition of regular acetaminophen (1g PO qid) leads to improved analgesic control in adult cancer patients at Princess Margaret Hospital, who are already on strong opioids (> 60mg morphine equivalents/day) as evaluated by daily pain scores measured by Numerical Rating Scales (NRS) and the Brief Pain Inventory (BPI).

Hypothesis:

Regular acetaminophen improves pain control in cancer patients who are already on strong opioid regimens.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients diagnosed with malignancy who have persistent pain which is believed by the investigator to be due to their cancer, and whose analgesic regimen has been stabilised on > 60mg of morphine equivalents/day.
Age > 18 years
Performance status of 0-2 by the European Co-operative Oncology Group (ECOG) Performance Scale
Sufficient English skills to be able to complete the daily diary, BPI and to understand the consent form
Signed informed consent

Exclusion Criteria:

Patient has no pain (0/10 on NRS).
Patients with severe pain are excluded, however once their pain control is optimised they are eligible.
Patient has received radiation therapy in the six weeks prior to commencing the study or is likely to require radiotherapy during the study period.
Patient has commenced, or had dose modifications, to either non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids in the week prior to commencing the study, or during the two-week study period.
Patient has commenced chemotherapy or hormone therapy in the 4 weeks prior to the study or is expected to commence chemotherapy or hormonotherapy during the study period. Patients who are stable on long-term chemotherapy or hormones are eligible for this study. Patients who receive high dose steroids as antiemetics with their chemotherapy are eligible providing they are not receiving the steroids during the study period.
Patient has a contraindication to acetaminophen.
Use of acetaminophen in the 48 hours prior to commencement of the study period.
Abnormal laboratory values:
- Absolute neutrophil count < 1.5 X 10^9/L and white blood cell (WBC) count < 3 X 10^9/L
- Platelet count < 100 X 10^9/L
- Liver transaminases > 2.5 X upper limit of normal
- Bilirubin > 1.5 X upper limit of normal
- Creatinine > 1.5 X upper limit of normal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152854

Contacts

Contact: Janette Vardy, MD	+61297675000	jvardy@med.usyd.edu.au
Contact: ian tannock, MD	1416 946 2245	ian.tannock@uhn.on.ca

Locations

Australia, New South Wales
Sydney Cancer Centre	Recruiting
Sydney, New South Wales, Australia, 2139
Contact: Janette Vardy, MD PhD +61297675000 jvardy@med.usyd.edu.au
Contact: Haryana Dhillon +61290365392 haryana@dhillon-pack.net
Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Ian Tannock, MD 1416 946 2245 ian.tannock@uhn.on.ca
Contact: David Warr, MD 1 416 946 4566 david.warr@uhn.on.ca
Principal Investigator: Janette Vardy, MD
Principal Investigator: David Warr, MD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:	Janette Vardy, MD	University Health Network, University of Toronto
Principal Investigator:	David Warr, MD	University Health Network, University of Toronto
Principal Investigator:	Ian Tannock, MD, PhD	University Health Network, University of Toronto

More Information

No publications provided

Responsible Party:	University Health Network ( Ian tannock )
Study ID Numbers:	ACETAPLAC
Study First Received:	September 8, 2005
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00152854 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

cancer pain
acetaminophen
opioids

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010