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

Not Applicable

Terminated

• Conditions: Chronic Myeloproliferative Disorders; Brain and Central Nervous System Tumors; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Pain; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific; Lymphoma; Lymphoproliferative Disorder
• Interventions: Drug: methadone hydrochloride; Drug: morphine sulfate; Drug: oxycodone hydrochloride

• Registration Number: NCT00726830
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Study Start: 2009-03
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Results First Submitted: 2012-11-09
• Results First Submitted QC: 2012-11-09
• Results First Posted: 2012-12-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I: Opioid rotation to oral methadone	methadone hydrochloride	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	morphine sulfate	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.
Arm II: Opioid rotation to another long-acting strong opioid	oxycodone 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items	28 days

Trial Locations

Locations (2)

Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center; 🇺🇸 Spartanburg, South Carolina, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States