Tokyo, April 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061357) titled 'A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders' on April 22.
Study Type:
Observational
Primary Sponsor:
Institute - University of Fukui
Condition:
Condition - Urological malignancies
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigates whether oral zinc supplementation reduces the incidence of drug-induced skin complications in patients newly initiated with molecularly targeted drugs, immune checkpoint inhibitors, androgen receptor inhibitors, or anti-Nectin-4 antibody-microtubule inhibitor conjugates.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients with solid tumors aged 20 years or older
2. Individuals scheduled to newly initiate EGFR-TKI, VEGFR-TKI, immune checkpoint inhibitor, anti-Nectin-4 antibody microtubule inhibitor conjugate (enfortumab vedotin), or androgen receptor inhibitor (apalutamide) at Fukui University Hospital between February 1, 2026 and December 31, 2027 [Fukui University 1.1]
3. Individuals with hypozincemia
4. Individuals with Grade 0 skin disorders at the time of registration
5. Individuals who can take the medication orally
6. Individuals who understand the research objectives and provide written consent.
Key exclusion criteria - 1. Individuals with pre-existing skin disorders
2. Individuals with zinc allergies or those who have previously experienced adverse reactions to zinc preparations
3. Individuals for whom zinc supplementation is deemed unsuitable, such as those with peptic ulcers
4. Individuals with hyperzincemia at the time of initial measurement
5. Pregnant or breastfeeding women, or those planning to become pregnant
6. Individuals whose attending physician deems participation in this study inappropriate
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 09 Day
Date of IRB - 2026 Year 03 Month 09 Day
Anticipated trial start date - 2026 Year 03 Month 09 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070190
Disclaimer: Curated by HT Syndication.
