UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031534 |
|---|---|
| Receipt number | R000036004 |
| Scientific Title | Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/03/14 10:03:43 |
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Basic information
Public title
Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Acronym
Hair loss restraint by scalp cooling enforcement
(Scalp cooling study)
Scientific Title
Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Scientific Title:Acronym
Hair loss restraint by scalp cooling enforcement
(Scalp cooling study)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of hair loss restraint by the scalp cooling enforcement addition for female breast cancer patients scheduled to receive chemotherapy causing high hair loss.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of grade 0 or 1 of hair loss, according to CTCAE ver4.0 classification
Key secondary outcomes
Rate of hair loss restraint in each evaluation timing
Hair loss accompanying symptom
Hair loss period
Safety
Adverse events
Influence of the hair loss after the chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
This study uses scalp cooling device (Paxman cooler, U.K.) for about 180 minutes during receiving chemotherapy.(30 minutes before and 90 minutes after chemotherapy)
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Histologically confirme breast cancer
2)Stage I, II or III
3)Female aged 20 to 75 years old.
4)The case for that is planned anthracycline, taxane-based chemotherapy and in that hair loss is expected.
5)No history of the chemotherapy for the malignant tumor
6)Signed informed consent of the patient for registration.
Key exclusion criteria
1)Chilly allergy
2)Cold agglutinin disease
3)Any scalp skin tumor
4)History of radiation for head
5)Temporomandibular disorder or disease to a chin
6)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Tokunaga |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Breast Oncology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka
TEL
092-541-3231
tokunaga.eriko.pw@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Chinami |
| Middle name | |
| Last name | Koga |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Breast Oncology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka
TEL
092-541-3231
Homepage URL
koga.chinami.qb@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Cancer Center
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
National Hospital Organization Kyushu Cancer Center
Address
3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka
Tel
092-541-3231
601-rinri@mail.hosp.go.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
独立行政法人国立病院機構 九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036004
