MDA 2007-0791 - "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"

NOTE:  Methadone prescriber training must be completed by investigators b/f randomizing patients.

Treatment Plan    (Supplied Drug:  None)

Calculate oral morphine equivalent daily dose (MEDD) of currently used strong opioid(s)

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RANDOMIZATION

Arm 1 - Switch to oral methadone-based opioid regimen

Arm 2 - Switch to either morphine or oxycodone SR

See protocol for dosing examples.  Training for prescribing, use, & titration of methadone is available via a webinar on the MD Anderson website or on disc by request.  A web-based clinical calculator is also available.

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Face-to-face asmt between Day 8 & 15

Telephone asmts for pain relief & toxicity on Days 8, 15, & 22 (not required on week when face-to-face asmt was made)

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Study completion visit Day 28 (+/- 3 days) to assess prim endpoint of pain control

Eligibility

• Age >18 w/ongoing care in outpt medical oncology.

• Self-reported pain (any cause) for which 1 of following long-acting strong opioids has been prescribed or administered:  morphine or oxycodone SR.  Physician may use short-acting strong or weak opioids at their discretion.

• Oral MEDD of opioids (long-acting or immed-release) is >40mg/day & <300mg/day.

• Worst pain score (0=no pain; 10=worst pain) of >5 of at least 1 week's duration based on verbal self-report &/OR >1 persistently bothersome symptom attributed to an opioid side effect.

• May also be receiving systemtic anticancer therapy of any kind or bisphosphonates if current therapy initiated >4 wks pre-study entry.

• May also be receiving tricyclic antidepressants, NSAIDs, anticonvulsants, and other adjuv analgesics or psychostimulants if current therapy was initiated >2 wks pre-study entry.  Doses of these agents should remain stable until after 1st wk of opioid rotation.  Pts should remain stable until at least the Day 8 asmt after initiation of opioid rotation.  Document use of above meds on concomitant med form.

• No use of same long-acting opioid pt is switching to (the new long-acting opioid) w/i 60 days pre-study enrollment. 

• No prior methadone therapy w/i 12 wks pre-study entry.

• No methadone maintenance therapy for opioid addiction.

• No current use of transdermal fentanyl, oxymorphone, or buprenorphine (w/i 3 days).

• No current use of intrathecal infusion of analgesics.

• No RT or surgery planned w/i 4 wks for local control of cancer or pain palliation.

• No known or suspected cognitive impairment to preclude medication adherence or self-report of symptoms/side effects.

• No condition to predispose pts to prolonged QT interval associated tachycardia: 

  • Cocaine abuse w/i past 3 mos

  • Serum potassium <3.0

  • Concurrent use of antiarrhthmic meds

  • Family hx of sudden death

  • Advanced heart failure (ejection fx <40% &/or NYHA Class III or IV)

  • Pregnant women (must have negative pregnancy test w/i 7 days pre-study regist [if applicable])

• PRESTUDY REQUIREMENTS (all at Baseline Day 0):

  • Review of # of Breakthrough Opioid doses/day (pts should maintain diary of breakthrough opioid doses they use)

  • Methadone OR long-acting opioid dose (mg/day)

  • MD Anderson Symptom Inventory

  • Composite Drug Toxicity Score

  • Revised Edmonton Staging System for Cancer Pain

  • ECOG perf status

  • PE

• Signed informed consent.