Cancer | Acetaminophen for Cancer Pain
Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. 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. 2. Age > 18 years 3. Performance status of 0-2 by the European Co-operative Oncology Group (ECOG) Performance Scale 4. Sufficient English skills to be able to complete the daily diary, BPI and to understand the consent form 5. Signed informed consent Exclusion Criteria: 1. Patient has no pain (0/10 on NRS). 2. Patients with severe pain are excluded, however once their pain control is optimised they are eligible. 3. Patient has received radiation therapy in the six weeks prior to commencing the study or is likely to require radiotherapy during the study period. 4. 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. 5. 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. 6. Patient has a contraindication to acetaminophen. 7. Use of acetaminophen in the 48 hours prior to commencement of the study period. 8. 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Acetaminophenacetaminophen 1g po qid
Drug:acetaminophenacetaminophen 1g po qid for 7 days
Drug:placebo, sugar pill
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
A, 1, acetaminophenacetaminophen
B placeboplacebo PO qid
Start Date: July 2005
Completed Date: December 2012
Phase: Phase 3
Primary Outcome: 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
Secondary Outcome: Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)
Study sponsors, principal investigator, and references
Principal Investigator: Janette Vardy, MD
Lead Sponsor: University Health Network, Toronto