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
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: 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
Interventions: Drug: methadone hydrochloride
Drug: morphine sulfate
Drug: oxycodone hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Arm I: Opioid Rotation to Oral Methadone     Arm II: Opioid Rotation to Another Long-acting Strong Opioid     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: years]
     
<=18 years     0         0  
Between 18 and 65 years     1         1  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     1         1  
Male     0         0  
Region of Enrollment  
[units: participants]
     
United States     1         1  



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items   [ Time Frame: 28 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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, MD, MPH, FACP
Organization: University of Texas MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


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