NCT00726830

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 6, 2012

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

July 31, 2008

Results QC Date

November 9, 2012

Last Update Submit

September 1, 2020

Conditions

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

Keywords

painunspecified adult solid tumor, protocol specificaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)atypical chronic myeloid leukemia, BCR-ABL1 negativeblastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiamast cell leukemiameningeal chronic myelogenous leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage III adult T-cell leukemia/lymphomastage III chronic lymphocytic leukemiastage IV adult T-cell leukemia/lymphomastage IV chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated hairy cell leukemiaadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaAIDS-related small noncleaved cell lymphomaAIDS-related lymphoblastic lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomasplenic marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III mycosis fungoides/Sezary syndromestage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV mycosis fungoides/Sezary syndromestage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomaHIV-associated Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomapost-transplant lymphoproliferative disorderchronic eosinophilic leukemiachronic neutrophilic leukemiaprimary myelofibrosisessential thrombocythemiapolycythemia veraextramedullary plasmacytomaisolated plasmacytoma of bonemonoclonal gammopathy of undetermined significancestage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisrefractory multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablecutaneous B-cell non-Hodgkin lymphomaWaldenström macroglobulinemia

Outcome Measures

Primary Outcomes (1)

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

    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).

    28 days

Secondary Outcomes (1)

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

    28 days

Study Arms (2)

Arm I: Opioid rotation to oral methadone

EXPERIMENTAL

Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.

Drug: methadone hydrochloride

Arm II: Opioid rotation to another long-acting strong opioid

EXPERIMENTAL

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.

Drug: morphine sulfateDrug: oxycodone hydrochloride

Interventions

oxycodone hydrochlorideDRUG

Given orally

Also known as: oxycodone, ETH-Oxydose, DSC, OxyIR, OxyContin, Roxicodone
Arm II: Opioid rotation to another long-acting strong opioid
methadone hydrochlorideDRUG

Given orally

Also known as: methadone, dolophine, methadose
Arm I: Opioid rotation to oral methadone
morphine sulfateDRUG

Given orally

Arm II: Opioid rotation to another long-acting strong opioid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsMyeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPainPrecancerous ConditionsLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Mast-CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, FollicularLymphoma, Mantle-CellIntraocular LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicPrimary MyelofibrosisThrombocythemia, EssentialPolycythemia VeraMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisWaldenstrom Macroglobulinemia

Interventions

MethadoneMorphineOxycodone

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, B-CellLeukemia, T-CellLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCodeine

Results Point of Contact

Title
Michael J. Fisch, MPH/Clinical Professor, General Oncology
Organization
University of Texas MD Anderson Cancer Center
mfisch@mdanderson.org
(713) 563-9905

Study Officials

  • Michael J. Fisch, MD, MPH, FACP

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • James D. Bearden, MD

    CCOP - Upstate Carolina

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 1, 2008

Study Start

March 1, 2009

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

September 24, 2020

Results First Posted

December 6, 2012

Record last verified: 2020-09

Locations

US(2)