An interventional study of methadone hydrochloride and morphine sulfate in Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders and Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
699 studies on the registry are indexed under Central Nervous System Neoplasms; 66 are open to participants now.
This study's enrollment of 1 is below the median of 35 across 487 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 -associated tachycardia:
PRIOR CONCURRENT THERAPY:
Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · Drug: oxycodone hydrochloride
Given orally
Also known as: methadone, dolophine, methadose
Given orally
Given orally
Also known as: oxycodone, ETH-Oxydose, DSC, OxyIR, OxyContin, Roxicodone
Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)
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
Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items
Time frame: 28 days
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.
| Milestone | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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).
No measurements were reported for this outcome.
Results for this outcome have not been posted.
Collected over 9 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I: Opioid Rotation to Oral Methadone | — | 0/1 (0%) | 0/1 (0%) |
| Arm II: Opioid Rotation to Another Long-acting Strong Opioid | — | — | — |
| Age, Categorical(Participants) | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 1 | — | 1 |
| >=65 years | 0 | — | 0 |
| Sex: Female, Male(Participants) | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 0 | — | 0 |
| Region of Enrollment(participants) | Arm I: Opioid Rotation to Oral Methadone | Arm II: Opioid Rotation to Another Long-acting Strong Opioid | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
The record gives a start of Mar 2009, a primary completion of Sep 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2012, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Methadone · Morphine · Oxycodone
Central Nervous System Neoplasms →