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

This study has been terminated.
(Low Accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00726830
First received: July 31, 2008
Last updated: November 9, 2012
Last verified: November 2012

July 31, 2008
November 9, 2012
March 2009
September 2010   (final data collection date for primary outcome measure)
Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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).
At least a 3-point reduction in pain score on the M.D. Anderson Symptom Inventory (MDASI) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00726830 on ClinicalTrials.gov Archive Site
Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • 30% reduction in patients' total summary score for the individual composite drug toxicity score (CDTS) items [ Designated as safety issue: Yes ]
  • Identification of 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 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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 Specific
  • Drug: methadone hydrochloride
    Given orally
    Other Names:
    • methadone
    • dolophine
    • methadose
  • Drug: morphine sulfate
    Given orally
  • Drug: oxycodone hydrochloride
    Given orally
    Other Names:
    • oxycodone
    • ETH-Oxydose
    • DSC
    • OxyIR
    • OxyContin
    • Roxicodone
  • Experimental: Arm I: Opioid rotation to oral methadone
    Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
    Intervention: Drug: methadone hydrochloride
  • Experimental: Arm II: Opioid rotation to another long-acting strong opioid
    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.
    Interventions:
    • Drug: morphine sulfate
    • Drug: oxycodone hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
October 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726830
2007-0791, MDA-2007-0791, CDR0000598283
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
Study Chair: James D. Bearden, MD CCOP - Upstate Carolina
M.D. Anderson Cancer Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP