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

• Status: Terminated
• Trial end date: 2012-01-06
• Target enrollment: 0
• Participant gender: All

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 first-line therapy in treating patients with chronic neuropathic cancer pain.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Methadone

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