Clinical trial NCT00930332 (phase 1, status: terminated)
Conditions: nausea and vomiting, pain, sleep disorders, unspecified adult solid tumor, protocol specific
ICD codes: R11.10, R11.12, R11.14, R11.11, K91.0, O21.2, O21.8, N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, G47.9, G47.21, G47.22, G47.23, G47.52, G47.29, G47.20, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: methadone hydrochloride
SMILES: CCC(=O)C(CC(C)N(C)C)(C1=CC=CC=C1)C1=CC=CC=C1
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        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