Status:
TERMINATED
Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wit...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00726830
Start Date
March 1 2009
End Date
October 1 2010
Last Update
September 24 2020
Active Locations (2)
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1
Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center
Spartanburg, South Carolina, United States, 29303
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009