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Status:

TERMINATED

Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Nausea and Vomiting

Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer. PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as fi...

Detailed Description

OBJECTIVES: Primary * To determine the optimum starting dose (defined as the dose that does not require modification within the first 4 days of treatment for lack of efficacy or the occurrence of ad...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Patients diagnosed with cancer and experiencing chronic neuropathic pain syndrome
  • Pain syndrome diagnosed by the investigator
  • Pain syndrome related to the effects of cancer or its treatment (i.e., chemotherapy, radiotherapy, and surgery)
  • Meets 1 of the following criteria:
  • Need to be started on strong opioids
  • Require an increase in opioid dose and are currently taking ≤ 75 mg of total daily dose of oral morphine equivalent
  • Experiencing pain for ≥ 4 weeks with an average pain score of ≥ 4 or a worst pain score of ≥ 5 (using the 0-10 Brief Pain Inventory Scale) during the past 24 hours
  • Requires strong opioids to control pain and is using an oral morphine-equivalent dose of 0-75 mg per day, on average, including breakthrough analgesia, within the past 3 full calendar days
  • Mixed pain syndrome allowed provided the neuropathic component is the predominant pain
  • Meets 1 of the following criteria:
  • Receiving concurrent chemotherapy but the chronic neuropathic pain is not related to this treatment and is not expected to improve or worsen because of this therapy
  • Received prior chemotherapy but discontinued treatment, has not received chemotherapy within the past 7 days, and no further chemotherapy is planned
  • No prior chemotherapy
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 40-100%
  • ALT and AST ≤ 3 times upper limit of normal (ULN)
  • Creatinine ≤ 2 times ULN
  • No other known laboratory abnormality that, in the investigator's opinion, would contraindicate study participation
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Mini-Mental State Examination score ≥ 25/30
  • Able to speak, read, and write in either English or French
  • Willing to complete study diary and questionnaires
  • Available for study treatment and follow up (i.e., within reasonable geographical limits of the participating center)
  • Able to swallow and tolerate oral medications
  • Patients with prior exposure to methadone hydrochloride must be able to tolerate it
  • No intractable nausea and vomiting
  • No presence or history of unstable disease or condition that would, in the investigator's opinion, preclude patient participation in study treatment, such as:
  • Head injury
  • Increased intracranial pressure
  • Uncontrolled seizures
  • Uncontrolled asthma
  • Decompensated chronic obstructive pulmonary disease
  • Untreated prostate hypertrophy
  • Acute abdominal conditions
  • Untreated hyperthyroidism and Addison disease
  • Increased cerebrospinal fluid pressure
  • Urethral stricture
  • Severe cardiac arrhythmias (especially prolonged QT interval)
  • Symptomatic hypotension
  • Toxic psychosis
  • Cor pulmonale
  • Sleep apnea
  • Severe obesity
  • Kyphoscoliosis
  • Myxedema
  • Central nervous system depression
  • Coma
  • No history of significant alcohol, analgesic, or narcotic substance abuse within the past 6 months
  • Able physically and mentally to answer questions and comply with study treatment
  • No patient who lives alone and cannot access at least 1 caregiver who can monitor on a daily basis at home
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 3 weeks since prior radiopharmaceutical treatment or radiotherapy
  • Concurrent co-analgesics and medications that can affect methadone hydrochloride metabolism allowed provided patients have been on a stable dose for the past 3-5 days and ≥ 5 half lives have passed since any change in dose
  • Not scheduled to start chemotherapy during the study treatment
  • Not planning on starting or discontinuing medication associated with modified methadone hydrochloride clearance during study treatment
  • No concurrent therapeutic procedure that is likely to influence pain intensity during the study period
  • No concurrent other opioid medications
  • No other concurrent methadone hydrochloride

Exclusion

    Key Trial Info

    Start Date :

    June 17 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 6 2012

    Estimated Enrollment :

    8 Patients enrolled

    Trial Details

    Trial ID

    NCT00930332

    Start Date

    June 17 2010

    End Date

    January 6 2012

    Last Update

    February 12 2024

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Cross Cancer Institute

    Edmonton, Alberta, Canada, T6G 1Z2

    2

    BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    3

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9