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Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer | Clinical Trials | Clareo Health

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

A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study

NCT00726830•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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
+16 more criteria

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

Key Dates

Start Date

March 1, 2009

Primary Completion Date

September 1, 2010

Completion Date

October 1, 2010

Last Updated

September 24, 2020

Enrollment

ACTUAL participants

Conditions

Brain and Central Nervous System TumorsChronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsPainPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific

Interventions

methadone hydrochloride

DRUG

morphine sulfate

DRUG

oxycodone hydrochloride

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

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