Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer
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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 |
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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 |
- 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).
- 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 |
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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.
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Drug: methadone hydrochloride
Given orally
Other Names:
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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.
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Drug: morphine sulfate
Given orally
Drug: oxycodone hydrochloride
Given orally
Other Names:
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
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 |
Study Chair: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
Study Chair: | James D. Bearden, MD | CCOP - Upstate Carolina |
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 Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms |
Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on February 24, 2013