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Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Pain Clinical Trial

Official title:
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

Clinical Trial 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 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

  • Brain and Central Nervous System Tumors
  • Central Nervous System Neoplasms
  • Chronic Myeloproliferative Disorders
  • Disease
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Nervous System Neoplasms
  • Pain
  • Precancerous Condition
  • Precancerous Conditions
  • Preleukemia
  • Syndrome
  • Unspecified Adult Solid Tumor, Protocol Specific
Clinical Trial Details
NCT number NCT00726830
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase N/A
Start date March 2009
Completion date October 2010
View Details
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