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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


N/A
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.

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

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome 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).

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Michael J. Fisch, MD, MPH, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0791

NCT ID:

NCT00726830

Start Date:

March 2009

Completion Date:

October 2010

Related Keywords:

  • 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
  • pain
  • unspecified adult solid tumor, protocol specific
  • accelerated phase chronic myelogenous leukemia
  • acute undifferentiated leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult 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 negative
  • blastic phase chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • mast cell leukemia
  • meningeal chronic myelogenous leukemia
  • progressive hairy cell leukemia, initial treatment
  • prolymphocytic leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult T-cell leukemia/lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • stage III adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated hairy cell leukemia
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • AIDS-related lymphoblastic lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • splenic marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • HIV-associated Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • intraocular lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • post-transplant lymphoproliferative disorder
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • primary myelofibrosis
  • essential thrombocythemia
  • polycythemia vera
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • monoclonal gammopathy of undetermined significance
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • cutaneous B-cell non-Hodgkin lymphoma
  • Waldenström macroglobulinemia
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Nervous System Neoplasms
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Central Nervous System Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Palmetto Hematology Oncology, PC at Gibbs Regional Cancer CenterSpartanburg, South Carolina  29303