Title
Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer
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
Phase
N/ALead Sponsor
University of Texas at HoustonStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Pain Precancerous Condition Unspecified Adult Solid Tumor, Protocol SpecificStudy Participants
1RATIONALE: 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
To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.
Secondary
To compare the tolerability of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).
To identify a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability.
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.
Arm I: Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.
Arm II: Patients currently receiving oxycodone are switched to sustained-release (SR) morphine. Patients currently receiving morphine are switched to SR oxycodone. Patients receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.
Given orally
Given orally
Given orally
Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
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 Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day 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: Serum potassium < 3.0 mg/dL Cocaine abuse within the past 3 months Family history of sudden death Advanced heart failure (ejection fraction < 40% and/or New York Heart Association (NYHA) class III or IV heart disease) 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 Dose expected to remain stable until after the first week of opioid rotation on study No concurrent methadone maintenance therapy for opioid addiction No concurrent intrathecal infusion of analgesics No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)
| Event Type | Organ System | Event Term |
|---|
MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The 'primary success' is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).
Outcome Measure Data Not Reported
