NCT00726830 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2020-09-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)

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outcome · NOT POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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 * Advanced heart failure (ejection fraction \< 40% and/or New York Heart Association (NYHA) class III or IV heart disease) * No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation * More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study * More than 12 weeks since prior methadone therapy * More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine * Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago * Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago * Dose expected to remain stable until after the first week of opioid rotation on study * No concurrent methadone maintenance therapy for opioid addiction * No concurrent intrathecal infusion of analgesics * No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: methadone hydrochloride
label
Arm I: Opioid rotation to oral methadone
type
EXPERIMENTAL
description
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.
intervention Names
Drug: morphine sulfate
Drug: oxycodone hydrochloride
label
Arm II: Opioid rotation to another long-acting strong opioid
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I: Opioid rotation to oral methadone
description
Given orally
name
methadone hydrochloride
other Names
methadone
dolophine
methadose
type
DRUG
arm Group Labels
Arm II: Opioid rotation to another long-acting strong opioid
description
Given orally
name
morphine sulfate
type
DRUG
arm Group Labels
Arm II: Opioid rotation to another long-acting strong opioid
description
Given orally
name
oxycodone hydrochloride
other Names
oxycodone
ETH-Oxydose
DSC
OxyIR
OxyContin
Roxicodone
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 1
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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).
measure
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

secondary Outcomes

measure
Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items
time Frame
28 days

Full study description

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.

Source references