A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study
A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study
RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer.
PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to their baseline opioid (morphine vs oxycodone). Patients are randomized to 1 of 2 treatment arms.
Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.
DISEASE CHARACTERISTICS:
Receiving ongoing care in the outpatient medical oncology setting
Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered
Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of ≥ 5 for ≥ 1 week duration based on verbal self-report AND/OR ≥ 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)
PATIENT CHARACTERISTICS:
None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:
No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation
More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study
More than 12 weeks since prior methadone therapy
More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine
Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago
Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago
No concurrent methadone maintenance therapy for opioid addiction
No concurrent intrathecal infusion of analgesics
No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)