Advanced urothelial carcinoma, Enfortumab vedotin-induced cutaneous adverse events Enfortumab vedotin, Padcev, Cutaneous adverse events, Zinc, Urothelial carcinoma
Conditions
Interventions
For urothelial cancer patients with low serum zinc levels (less than 80 ug/dL) at screening, zinc supplementation therapy (e.g., zinc acetate hydrate) will be administered concurrently with the initia
Sponsors
Aya Nishizawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 years or older who have provided written informed consent. 2. Patients diagnosed with advanced urothelial carcinoma. 3. Patients scheduled to receive treatment with enfortumab vedotin (EV). 4. Patients with good performance status (ECOG PS 0-2).
Exclusion criteria
Exclusion criteria: 1. Patients who have already started treatment with enfortumab vedotin (EV). 2. Patients with a history of hypersensitivity to zinc preparations. 3. Patients with severe comorbidities (e.g., uncontrolled diabetes, active infection). 4. Patients judged ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 or higher cutaneous adverse events (according to CTCAE v5.0) within 3 months after the initiation of enfortumab vedotin (EV) treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of cutaneous adverse events (all Grades) 2. Incidence of dysgeusia (taste disorder) 3. Rates of dose reduction, interruption, and discontinuation of EV 4. Continuation rate of EV treatment 5. Time to onset of cutaneous adverse events 6. Time to recovery from cutaneous adverse events 7. Changes in serum zinc levels over time | — |
Contacts
Public ContactNishizawa Aya
Department of Dermatology and Dermatologic Oncology, Tokyo Metropolitan Komagome Hospital
Outcome results
None listed