Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI) [28 days]
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 [28 days]
Eligibility Criteria
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
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Advanced heart failure (ejection fraction < 40% and/or New York Heart Association (NYHA) class III or IV heart disease)
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No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects
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Not pregnant or nursing
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
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More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation
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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
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More than 12 weeks since prior methadone therapy
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More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine
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Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago
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Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago
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Dose expected to remain stable until after the first week of opioid rotation on study
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No concurrent methadone maintenance therapy for opioid addiction
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No concurrent intrathecal infusion of analgesics
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No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center | Spartanburg | South Carolina | United States | 29303 |
| 2 | M. D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Michael J. Fisch, MD, MPH, FACP, M.D. Anderson Cancer Center
- Study Chair: James D. Bearden, MD, CCOP - Upstate Carolina
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2007-0791
- MDA-2007-0791
- CDR0000598283
Study Results
Participant Flow
| Recruitment Details | Recruitment Period: March 10, 2009 to October 1, 2010. Recruitment occured within University of Texas MD Anderson Cancer Center and Palmetto Hematology Oncology at Gibbs Regional Cancer Center. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid |
|---|---|---|
| Arm/Group Description | Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks. | 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. |
| Period Title: Overall Study | ||
| STARTED | 1 | 0 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | Total |
|---|---|---|---|
| Arm/Group Description | Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks. | 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. | Total of all reporting groups |
| Overall Participants | 1 | 0 | 1 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
NaN
|
|
| Between 18 and 65 years |
1
100%
|
1
Infinity
|
|
| >=65 years |
0
0%
|
0
NaN
|
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
100%
|
1
Infinity
|
|
| Male |
0
0%
|
0
NaN
|
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
1
Infinity
|
|
Outcome Measures
| Title | Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI) |
|---|---|
| Description | 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). |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| No Analysis accomplished as there is not sufficient participant data to meet the study end points. |
| Arm/Group Title | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid |
|---|---|---|
| Arm/Group Description | Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks. | 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. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items |
|---|---|
| Description | |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 9 Months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | ||
| Arm/Group Description | Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks. | 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. | ||
All Cause Mortality |
||||
| Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Michael J. Fisch, MPH/Clinical Professor, General Oncology |
|---|---|
| Organization | University of Texas MD Anderson Cancer Center |
| Phone | (713) 563-9905 |
| mfisch@mdanderson.org |
- 2007-0791
- MDA-2007-0791
- CDR0000598283