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| 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 |
| 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.
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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
|
OBJECTIVES:
Primary
Secondary
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.
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 |
DISEASE CHARACTERISTICS:
Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered
PATIENT CHARACTERISTICS:
None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:
PRIOR CONCURRENT THERAPY:
Concurrent tricyclic antidepressants, NSAIDs, anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago
Contacts and 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 | |
| Study Chair: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
| Investigator: | James D. Bearden, MD | CCOP - Upstate Carolina |
More Information
| 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 |
|
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 |
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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 |