Health Condition 1: C768- Malignant neoplasm of other specified ill-defined sites
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
MPMMCC and HBCH Varanasi UP India
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed malignancy with moderate-to-severe pain. VAS more than 4 Opioid-naive or off opioids for more than 7 days Expected survival of more than 4 weeks Able to provide informed consent
Exclusion criteria
Exclusion criteria: Known prolonged QTc more than 450 ms or arrhythmia Severe hepatic dysfunction Child-Pugh C Concurrent use of QT-prolonging medications Cognitive impairment precluding accurate pain assessment, Pregnancy, or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of methadone as a first-line opioid for moderate to severe cancer-related pain, measured by achievement of more than 50% reduction in pain intensity on the Visual Analogue Scale (VAS) over a 14-day periodTimepoint: Day 0, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety & tolerability of methadone by documenting the incidence of adverse effects, including sedation, nausea, constipation, & QT interval prolongationTimepoint: Baseline, 2 weeks; To evaluate changes in quality of life using validated assessment tools, such as EORTC QLQ-C15-PAL questionnaire.Timepoint: Baseline, 2 weeks; To determine dose stability & time required to achieve adequate pain control.Timepoint: Baseline, 2 weeks; To identify clinical predictors of analgesic response, including pain characteristics, baseline QTc interval, & renal & hepatic function.Timepoint: Baseline, 2 weeks | — |
Countries
India
Contacts
Public ContactSOMNATH DEY
Tata Memorial Centre Varanasi
Outcome results
None listed