Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Methadone: Patients will receive a fixed dose of oral methadone 2.5 mg once daily in addition to their Standard of Care (SOC) analgesic regimen. No dose titration will be performed
Cont
Sponsors
Cachar Cancer Hospital And Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than 18 years. 2. Histopathologically confirmed diagnosis of Head and Neck Cancer (HNC). 3. Presence of a neuropathic pain component, diagnosed with a Douleur Neuropathique 4 (DN4) scale score greater than or equal to 4. 4. No significant cardiac co-morbidities and a normal baseline Electrocardiogram (ECG). 5. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergy to methadone. 2. Severe hepatic impairment. 3. Baseline QTc interval greater than 450ms on ECG. 4. Pregnancy or breastfeeding. 5. Concurrent use of medications known to have major interactions with methadone or prolong the QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the change in the mean NRS pain score from Baseline (Day 0) to the final assessment (Week 4) between the Test Group and the Control Group.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total daily opioid dose (MME) from baselineTimepoint: 4 weeks;Incidence of adverse eventsTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactVishnuprasad MA
Cachar cancer hospital and research centre
Outcome results
None listed