UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062575 |
|---|---|
| Receipt number | R000071625 |
| Scientific Title | A Prospective Within-Patient Self-Controlled Study of Localized Hand Cooling for the Prevention of Peripheral Neuropathy Induced by Enfortumab Vedotin plus Pembrolizumab (EVP) |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/08/14 01:47:55 |
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Basic information
Public title
A Study to Investigate Whether Hand Cooling Can Prevent Numbness of the Hands Caused by Anticancer Therapy (EVP)
Acronym
HANDS study
Scientific Title
A Prospective Within-Patient Self-Controlled Study of Localized Hand Cooling for the Prevention of Peripheral Neuropathy Induced by Enfortumab Vedotin plus Pembrolizumab (EVP)
Scientific Title:Acronym
HANDS Study
Region
| Japan |
Condition
Condition
urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether localized hand cooling can prevent sensory peripheral neuropathy induced by monomethyl auristatin E (MMAE), the payload of enfortumab vedotin (EV), in patients receiving enfortumab vedotin plus pembrolizumab (EVP) as first-line therapy for locally advanced or metastatic urothelial carcinoma, using a within-patient self-controlled design comparing the two hands of each patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The between-hand difference in the proportion of participants who develop moderate or greater (equivalent to CTCAE Grade 2) sensory peripheral neuropathy, comparing the intervention side (cooled dominant hand) with the control side (non-cooled non-dominant hand), within 6 months after the start of EVP therapy or by the end of treatment. Peripheral neuropathy in each hand is assessed using a patient-reported, hand-specific questionnaire.
Key secondary outcomes
1. Objective sensory function: the between-hand difference (intervention vs. control side) in vibration perception time measured with a 128-Hz tuning fork (time until vibration is no longer perceived), assessed for each hand at baseline and at the end of treatment by an assessor blinded to the intervention side. This is positioned as the principal objective corroboration compensating for the lack of patient blinding.
2. Safety and tolerability: the incidence of cooling-related discomfort/pain (NRS 0-10) and skin adverse events (frostbite, erythema, blistering, etc.).
3. The between-hand difference (intervention vs. control side) in the questionnaire-based sensory peripheral neuropathy symptom score (0-3), analyzed as a continuous variable (exploratory comparison).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
On the intervention side (dominant hand), localized hand cooling is performed on each EV administration day (Day 1 and Day 8 of every cycle) by applying a frozen glove over a thin cotton glove for approximately 90 minutes in total, from 30 minutes before infusion, during infusion, until 30 minutes after the end of infusion. The control side (non-dominant hand) receives no application. Cooling is repeated on every EV administration day during EVP therapy, up to 6 months or until the end of treatment.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed urothelial carcinoma (including variant histology).
(2) Scheduled to start enfortumab vedotin plus pembrolizumab (EVP) as first-line therapy for locally advanced or metastatic urothelial carcinoma.
(3) ECOG Performance Status 0 to 2.
(4) Age 20 years or older at the time of consent.
(5) Written informed consent for study participation has been obtained.
Key exclusion criteria
(1) Peripheral neuropathy of Grade 1 or higher at baseline (e.g., diabetic neuropathy or pre-existing chemotherapy-induced peripheral neuropathy).
(2) Severe circulatory disorder or skin disease of the fingers/hands (e.g., severe Raynaud's phenomenon, cold intolerance, cryoglobulinemia) for which cooling is deemed inappropriate.
(3) Regular use of drugs that may mask neuropathic symptoms (e.g., duloxetine, pregabalin, mirogabalin).
(4) Any other condition judged inappropriate by the principal investigator or sub-investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Tomiyama |
Organization
Sakai city medical center
Division name
Urology
Zip code
593-8304
Address
1-1-1 Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan
TEL
072-272-1199
tomiyama@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Tomiyama |
Organization
Sakai city medical center
Division name
Urology
Zip code
593-8304
Address
1-1-1 Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan
TEL
072-272-1199
Homepage URL
tomiyama@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Sakai city medical center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Sakai City Medical Center
Address
1-1-1 Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan
Tel
072-272-1199
kenkyu@sakai-hospital.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 | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071625
