Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain
TerminatedPhase 1NCT00930332
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Brief summary (from the registry)
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.
Study details
- Official title
- A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain
- Conditions
- Nausea and Vomiting
- Pain
- Sleep Disorders
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Drug: methadone hydrochloride
- Other: questionnaire administration
- Procedure: management of therapy complications
- Sponsor
- NCIC Clinical Trials Group
- Organization
- Canadian Cancer Trials Group
- Start date
- 2010-06-17
- Primary completion
- 2012-01-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 * I…
Canadian sites (7)
| Facility | City | Province |
|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta |
| BCCA - Cancer Centre for the Southern Interior | Kelowna | British Columbia |
| BCCA - Vancouver Cancer Centre | Vancouver | British Columbia |
| CancerCare Manitoba | Winnipeg | Manitoba |
| Cancer Centre of Southeastern Ontario at Kingston | Kingston | Ontario |
| Univ. Health Network-Princess Margaret Hospital | Toronto | Ontario |
| McGill University - Dept. Oncology | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00930332