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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00152854 |
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 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomised, Placebo-Controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids |
Estimated Enrollment: | 60 |
Study Start Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal laboratory values:
Contact: Janette Vardy, MD | 1416 946 2245 | janette.vardy@uhn.on.ca |
Contact: David Warr, MD | 1416 946 4566 | david.warr@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Janette Vardy, MD 1416 946 2245 janette.vardy@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 |
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 |
Study ID Numbers: | ACETAPLAC |
Study First Received: | September 8, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00152854 |
Health Authority: | Canada: Health Canada |
cancer pain acetaminophen opioids |
Pain Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |