UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061357 |
|---|---|
| Receipt number | R000070190 |
| Scientific Title | A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders. |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/22 20:23:36 |
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Basic information
Public title
A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders.
Acronym
A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders.
Scientific Title
A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders.
Scientific Title:Acronym
A prospective observational study to explore the efficacy of oral zinc supplementation in patients with anticancer drug-associated skin disorders.
Region
| Japan |
Condition
Condition
Urological malignancies
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of drug-induced skin disorders
Key secondary outcomes
DLQI, PRO-CTCAE
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Okumura |
| Middle name | |
| Last name | Yoshinaga |
Organization
University of Fukui
Division name
Department of Urology
Zip code
9101193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
TEL
0776618174
urokumura@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
Department of Urology
Zip code
9101193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
TEL
0776618174
Homepage URL
urokumura@gmail.com
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
YOshinaga Okumura
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
Tel
0776-61-8758
tokutei@ml.u-fukui.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is nothing in particular.
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070190
