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Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: July 31, 2008   Last Updated: January 27, 2010   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00726830
  Purpose

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.


Condition Intervention
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Pain
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Drug: methadone hydrochloride
Drug: morphine sulfate
Drug: oxycodone hydrochloride

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • At least a 3-point reduction in pain score on the M.D. Anderson Symptom Inventory (MDASI) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.
Drug: methadone hydrochloride
Given orally
Arm II: Experimental
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.
Drug: morphine sulfate
Given orally
Drug: oxycodone hydrochloride
Given orally

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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, 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726830

Locations
United States, South Carolina
Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: James D. Bearden, MD     864-560-6812     jbearden@srhs.com    
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Michael J. Fisch, MD, MPH, FACP     713-563-0276        
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
Investigator: James D. Bearden, MD CCOP - Upstate Carolina
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000598283, MDA-2007-0791
Study First Received: July 31, 2008
Last Updated: January 27, 2010
ClinicalTrials.gov Identifier: NCT00726830     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
pain
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage III adult T-cell leukemia/lymphoma
stage III chronic lymphocytic leukemia
stage IV adult T-cell leukemia/lymphoma
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
untreated adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Respiratory System Agents
Precancerous Conditions
Blood Protein Disorders
Physiological Effects of Drugs
Oxycodone
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Analgesics
Lymphoma
Analgesics, Opioid
Morphine
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 04, 2010