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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00930332
• Date of registration: 27/06/2009
• Primary sponsor: NCIC Clinical Trials Group
• Public title: Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain
• Scientific title: A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain
• Date of first enrolment: April 2009
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00930332
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

Canada

Contacts

• Name: Ray Viola
• Affiliation: Kingston General Hospital

• Name: Bruno Gagnon, MD, MSC
• Affiliation: McGill Cancer Centre at McGill University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Nausea and Vomiting

Pain

Sleep Disorders

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Drug: methadone hydrochloride

Other: questionnaire administration

Procedure: management of therapy complications

Primary Outcome(s)

Optimum starting dose [Time Frame: 28 days]

Secondary Outcome(s)

Adverse events (including respiratory depression) according to NCI CTCAE v3.0 criteria [Time Frame: 28 days]

Feasibility of recruiting patients [Time Frame: 28 days]

Frequency and severity of sleep disturbance from pain [Time Frame: 28 days]

Pain control as assessed by the number and timing of breakthrough analgesics, the number of episodes of breakthrough pain, the total daily dose of methadone, and the average pain scores [Time Frame: 28 days]

Secondary ID(s)

CAN-NCIC-SC22

CDR0000641372

SC22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors