Health Condition 1: G620- Drug-induced polyneuropathy
Conditions
Interventions
Intervention1: Etifoxine: 50 mg orally three times daily, starting 7 days before the first dose of taxane for 12 weeks
Intervention2: Etifoxine: 50 mg orally three times daily, starting 7 days before
Sponsors
IGIMS
Eligibility
Inclusion criteria
Inclusion criteria: Scheduled to receive taxane based chemotherapy for any cancer No pre existing peripheral neuropathy Able to provide informed consent Life expectancy more than 6 months
Exclusion criteria
Exclusion criteria: Any pre existing disease known to cause neuropathy such as Diabetes mellitus Family or personal history of hereditary neuropathy Chronic Alcohol intake Vitamin B12 deficiency Aggressive cancers requiring urgent chemotherapy Concurrent use of other neuroprotective agents or anxiolytics Severe renal or hepatic impairment Myasthenia gravis Hypersentivity to Etifoxine Pregnancy or breastfeeding Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade greater than or equal to 2 Peripheral Sensory Neuropathy as per NCI CTCAE v5 at any time during the studyTimepoint: Follow up after each cycle of chemotherapy for 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PNQ scoresTimepoint: Follow up after each cycle of chemotherapy for 6 cycles;Change in HADS scoresTimepoint: Follow up after each cycle of chemotherapy for 6 cycles;Change in Numeric Rating Scale (NRS) for neuropathic pain intensityTimepoint: Follow up after each cycle of chemotherapy for 6 cycles;Adverse events and safety assessmentsTimepoint: Follow up after each cycle of chemotherapy for 6 cycles | — |
Countries
India
Contacts
Public ContactSyed Sharjil Anees
IGIMS, Patna
Outcome results
None listed