UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058454 |
|---|---|
| Receipt number | R000066434 |
| Scientific Title | Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/14 08:07:47 |
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Basic information
Public title
Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study
Acronym
Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study
Scientific Title
Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study
Scientific Title:Acronym
Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is a pilot study aimed at exploring the effect of intraoral cooling as a preventive measure against chemotherapy-induced taste dysfunction in patients with early-stage breast cancer. The objectives are to assess the incidence and severity of taste dysfunction (based on patient-reported outcomes and healthcare provider assessments), as well as the safety and feasibility of intraoral cooling, in order to collect foundational data for a larger-scale study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of taste dysfunction based on patient-reported outcomes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ice chips or ice water
Interventions/Control_2
usual care
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 aged 20 years or older
2. Patients with histologically confirmed primary breast cancer
3. Patients scheduled to receive any of the following as adjuvant therapy for early-stage breast cancer:
-Dose-dense doxorubicin + cyclophosphamide (AC) / epirubicin + cyclophosphamide (EC) with or without docetaxel (DTX) or paclitaxel (PTX)
-Docetaxel + cyclophosphamide (TC)
-Trastuzumab + paclitaxel (HT)
-Trastuzumab + docetaxel (HDTX)
-As neoadjuvant therapy: pembrolizumab (Pembro), PTX, and carboplatin (CBDCA), followed by Pembro + AC or EC
4. Patients without taste dysfunction
5. Patients capable of using electronic devices
6. Patients who can provide written informed consent of their own free will
Key exclusion criteria
1. Determined by the attending physician to be inappropriate for inclusion in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Kawasaki Medical School Hospital
Division name
Breast and Thyroid Surgery
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama, Japan
TEL
+81-86-462-1111
ntaira@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Iwamoto |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama, Japan
TEL
+81-86-462-1111
Homepage URL
tiwamoto@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki City, Okayama, Japan
Tel
NA
NA
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 | 07 | Month | 17 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | 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 | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066434
