Urothelial carcinoma
Conditions
Interventions
From the evening before the initiation of the standard EV dose until Day 28, dermovate ointment and Vaseline ointment are applied twice daily in the morning and evening to the right axilla/groin and l
Sponsors
Kita Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients receiving EV at the standard dose (1.25 mg/kg) for the treatment of unresectable urothelial carcinoma that has progressed after chemotherapy. 2. Patients must be at least 18 years of age at the time of consent. 3. Patients who have given written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of EV administration. 2. Patients participating in other clinical studies or trials involving interventions within 1 month prior to obtaining consent. 3. Patients treated with systemic steroid therapy (prednisolone equivalent >10 mg/day) within 2 weeks prior to the first dose of EV 4. Patients with an ECOG Performance Status of 3 or higher. 5. Patients with poorly controlled eczema, atopic dermatitis, psoriasis vulgaris, or autoimmune bullous disease. 6. Patients who are judged by the investigators or subinvestigators to be unsuitable for the safe conduct of this study. Translated with www.DeepL.com/Translator (free version)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of grade 2 or higher skin reactions according to CTCAE v5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, presence of all grades of skin reactions up to 4 weeks of EV treatment, IGA (investigators global assessment) score on each side of the body at visit date and at discontinuation up to 4 weeks of EV treatment, pain and pruritus scale on each side of the body up to 4 weeks of EV treatment | — |
Contacts
Public ContactYuki Kita
Kyoto University Hospital
Outcome results
None listed