Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Pharmacogenetic-guided opioid dosing: In the intervention arm, the prescribing physician will receive the patient s pharmacogenetic report before initiating opioid therapy. The report i
UGT2B7, OPRM1, and COMT for tapentadol). Based on these results, along with clinical assessment, the physician will determine the initial dose and perform subsequent dose adjustments (titration) accor
Sponsors
Kasturba Medical College, Manipal
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (above or equal to 18 years) receiving palliative care for advanced or metastatic cancer will be eligible for inclusion. Patients who are being initiated on oral morphine or tapentadol therapy for cancer-related pain, as per the treating physician s clinical judgment, will be considered. Participants should have an expected survival of at least 3 months from the time of enrolment. Additionally, patients must be able to provide written informed consent either personally or through a legally authorized representative.
Exclusion criteria
Exclusion criteria: Patients with prior or ongoing use of strong opioids (such as morphine, tapentadol, fentanyl, methadone, or oxycodone) within the preceding 30 days will be excluded. Individuals with known hypersensitivity or contraindications to morphine or tapentadol will not be eligible. Patients with severe hepatic or renal impairment will also be excluded. Those with cognitive impairment or delirium that precludes reliable pain assessment will not be included. Pregnant or lactating women will be excluded. Additionally, patients currently enrolled in another interventional clinical trial will not be eligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental cost-effectiveness ratio on numeric rating scale for pain at 3rd monthTimepoint: 3 months (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Genotype results (of UGT2B7, OPRM1, ABCB1, COMT) in morphine and (UGT2B7, OPRM1, COMT for Tapentadol)Timepoint: At baseline (before first opioid dose).;Time to adequate pain control, defined as the duration from opioid initiation to achieving and maintaining an NRS score less than or equal to 3 for at least 24 hoursTimepoint: Assessed from baseline up to 6 months.;Incidence and severity of opioid-related adverse events, including nausea, vomiting, constipation, sedation, and neurotoxicity, assessed using standard clinical criteria.Timepoint: Assessed from 48-72hrs to 12 weeks.;Proportion of patients requiring opioid rotation or significant dose escalation due to inadequate analgesia or intolerable side effects.Timepoint: Assessed from week 1 to 12 weeks.;Patient satisfaction with pain management, measured using a Likert scaleTimepoint: Assessed on week 4 and 12.;Healthcare utilization, including the number of unscheduled hospital visits, emergency department visits, or re-admissions related to pain or opioid complications.Timepoint: Assessed from week 1 to 6 months.;Medication adherence, evaluated using pill counts.Timepoint: Assessed on week 1, 4 and 12.;Change in health-related quality of life (HRQoL) from baseline to study end, assessed using tools like EQ-5D-5L.Timepoint: Assessed at baseline, 12 weeks (end of follow-up), and 6 months (exploratory follow-up).;Net monetary benefit (NMB), calculated to support economic evaluation alongside ICER for decision-analytic modeling.Timepoint: Assessed at 12 weeks.;Ongoing opioid use, general health status, and quality of life and Documentation of Survival Status.Timepoint: Assessed at 6 months. | — |
Countries
India
Contacts
Public ContactJeffrey Pradeep Raj
Kasturba Medical College Manipal
Outcome results
None listed