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
  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
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
Drug: morphine sulfate
Drug: oxycodone hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Leukemia, Myeloid Chronic Myeloid Leukemia Multiple Myeloma Lymphosarcoma Mantle Cell Lymphoma B-cell Lymphomas Burkitt Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Hodgkin Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Leukemia, T-cell, Chronic Myelofibrosis Waldenstrom Macroglobulinemia Anaplastic Large Cell Lymphoma Small Non-cleaved Cell Lymphoma Chronic Myelomonocytic Leukemia Hairy Cell Leukemia Lymphomatoid Granulomatosis Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hypereosinophilic Syndrome Polycythemia Vera Chronic Myeloproliferative Disorders Essential Thrombocythemia Myelodysplastic/myeloproliferative Disease Anaplastic Plasmacytoma Large Granular Lymphocyte Leukemia AL Amyloidosis Chronic Neutrophilic Leukemia Central Nervous System Lymphoma, Primary Systemic Mastocytosis Monoclonal Gammopathy of Undetermined Significance
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: March 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: methadone hydrochloride
Given orally
Other Names:
  • methadone
  • dolophine
  • methadose
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.
Drug: morphine sulfate
Given orally
Drug: oxycodone hydrochloride
Given orally
Other Names:
  • oxycodone
  • ETH-Oxydose
  • DSC
  • OxyIR
  • OxyContin
  • Roxicodone

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Spartanburg, South Carolina, United States, 29303
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
Study Chair: James D. Bearden, MD CCOP - Upstate Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00726830     History of Changes
Other Study ID Numbers: 2007-0791, MDA-2007-0791, CDR0000598283
Study First Received: July 31, 2008
Results First Received: November 9, 2012
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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, BCR-ABL1 negative
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:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Disease
Syndrome
Nervous System Neoplasms
Central Nervous System Neoplasms
Plasmacytoma
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Precancerous Conditions
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Lymphatic Diseases
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on September 18, 2014