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
- 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.
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)
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).
Michael J. Fisch, MD, MPH, FACP
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center||Spartanburg, South Carolina 29303|