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Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00726830
Recruitment Status : Terminated (Low Accrual.)
First Posted : August 1, 2008
Results First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 1
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 Details  
Arm/Group Title Arm I: Opioid Rotation to Oral Methadone Arm II: Opioid Rotation to Another Long-acting Strong Opioid
Hide 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
Arm/Group Title Arm I: Opioid Rotation to Oral Methadone Arm II: Opioid Rotation to Another Long-acting Strong Opioid Total
Hide 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 Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 1
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items
Hide Description [Not Specified]
Time Frame 28 days
Outcome Measure Data Not Reported
Time Frame 9 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Opioid Rotation to Oral Methadone Arm II: Opioid Rotation to Another Long-acting Strong Opioid
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: Opioid Rotation to Oral Methadone Arm II: Opioid Rotation to Another Long-acting Strong Opioid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I: Opioid Rotation to Oral Methadone Arm II: Opioid Rotation to Another Long-acting Strong Opioid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
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
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00726830     History of Changes
Other Study ID Numbers: 2007-0791
MDA-2007-0791
CDR0000598283 ( Other Identifier: NCI Identifier )
First Submitted: July 31, 2008
First Posted: August 1, 2008
Results First Submitted: November 9, 2012
Results First Posted: December 6, 2012
Last Update Posted: December 6, 2012