UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058003 |
|---|---|
| Receipt number | R000066294 |
| Scientific Title | COOL study |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/05/28 17:40:45 |
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Basic information
Public title
CryOtherapy tO prevent OraL mucositis in Patients with Breast Cancer Receiving Dato-DXd: A Pilot Study
Acronym
COOL study
Scientific Title
COOL study
Scientific Title:Acronym
COOL study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of cryotherapy for oral mucositis in patients with breast cancer receiving Dato-DXd.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of oral mucositis by Day 56 from treatment initiation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The cryotherapy in this study will be performed according to the following procedure:
1. Begin oral cooling by placing ice chips or ice pops in the mouth starting 5 minutes before the administration of Dato-DXd.
2. Continue oral cooling throughout the Dato-DXd infusion.
3. Maintain oral cooling for an additional 5 minutes after the completion of Dato-DXd administration.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patient has been histologically diagnosed with invasive breast cancer.
2. The patient has been diagnosed with metastatic or recurrent breast cancer.
3. The patient is 18 years of age or older at the time of consent.
4. The patient has a performance status (PS) of 0 or 1.
5. The patient is scheduled to receive Dato-DXd treatment.
6. Written informed consent for participation in the study has been obtained.
Key exclusion criteria
1. The patient has oral mucositis prior to study enrollment.
2. The patient is pregnant or breastfeeding.
3. The patient has an active infection requiring treatment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | TAKESHI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Toranomon hospital
Division name
Department of medical oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
takyamag@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | TAKESHI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Toranomon hospital
Division name
Department of medical oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
takyamag@toranomon.gr.jp
Sponsor or person
Institute
Toranomon hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital Institutional Review Board
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2025 | Year | 06 | Month | 16 | 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
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066294
