Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cance… (NCT00930332) | Clinical Trial Compass
TerminatedPhase 1
Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain
Stopped: Poor accrual
Canada8 participantsStarted 2010-06-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tha…