UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056296 |
|---|---|
| Receipt number | R000063964 |
| Scientific Title | The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/05/30 12:43:08 |
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Basic information
Public title
The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study
Acronym
The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study
Scientific Title
The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study
Scientific Title:Acronym
The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Gynecologic Malignancies
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the safety and efficacy of scalp cooling therapy for preventing chemotherapy-induced hair loss in patients with gynecologic malignancies, with the goal of establishing and promoting scalp cooling therapy in the field of gynecologic oncology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of hair loss prevention after six courses of TC or TCBEV therapy combined with scalp cooling therapy following radical surgery in patients with gynecologic malignancies.
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
If the following criteria are met, the attending physician will confirm eligibility on the case registration form and proceed with enrollment:
Diagnosis of a gynecologic malignancy cervical cancer, endometrial cancer, or ovarian cancer.
Radical surgery has been performed.
Six cycles of TC or TCBEV therapy are planned as postoperative adjuvant chemotherapy.
Aged 20 years or older and under 80 years.
Performance Status 0 - 2.
Major organ functions are preserved.
Patient is willing to undergo anticancer therapy combined with scalp cooling therapy.
Written informed consent for participation in the study has been obtained from the patient.
Key exclusion criteria
(1) Skin diseases on the scalp
(2) Alopecia (especially male-generated alopecia)
(3) History of treatment with head radiation therapy
(4)Allergy to Paclitaxel or Carboplatin
(5) Allergy to silicone
(6) Pregnant, lactating, may be pregnant, or intend to become pregnant
(7) Ischemic heart disease (angina pectoris or myocardial infarction), concomitant cardiomyopathy, or history of cardiomyopathy
(8) Has an active infection
(9) Interstitial pneumonia or pulmonary fibrosis
(10) Poorly controlled diabetes mellitus (HbA1c(NGSP) > 10.0%)
(11) Concurrent overlapping cancers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | SHINYA |
| Middle name | |
| Last name | OKI |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
ooki@keio.jp
Public contact
Name of contact person
| 1st name | SHINYA |
| Middle name | |
| Last name | OKI |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
ooki@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-ft_pt@adst.keio.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
| 2025 | Year | 01 | Month | 01 | 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
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 01 | 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
no specific data
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063964
