UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036472 |
|---|---|
| Receipt number | R000041384 |
| Scientific Title | A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan |
| Date of disclosure of the study information | 2019/04/11 |
| Last modified on | 2019/04/11 16:32:47 |
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Basic information
Public title
A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan
Acronym
HOPE study
Scientific Title
A Multicenter controlled trial of PAX-15 Hair Loss Prevention System with chemotherapy-induced alopecia in breast cancer patients in Japan
Scientific Title:Acronym
HOPE study
Region
| Japan |
Condition
Condition
Female patients with stage I/II primary breast cancer who were scheduled to undergo adjuvant/neoadjuvant chemotherapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of scalp cooling devices to prevent chemotherapy-induced alopecia in Japanese breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with no alopecia after the 4th cycle of chemotherapy treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Scalp cooling by scalp cooling device is done 30 minutes pre-chemotherapy, duration of chemotherapy and more than 90 minutes post-chemotherapy.
Interventions/Control_2
No cooling
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. New diagnosis of breast cancer stage 1-2
2. Female with Age >= 20 and age <= 70
3. Planning to undergo 4 cycles of adjuvant/neoadjuvant chemotherapy by following regimens:
- AC (Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2)
- EC (Epirubicin 100 mg/m2 with cyclophosphamide 600 mg/m2)
- TC (Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2)
- FEC (Epirubicin100 mg/m2 with 5-Fluroruacil 500 mg/m2 and cyclophosphamide 500 mg/m2)
A dose dense schedule is not allowed.
4. Written informed consent
Key exclusion criteria
1. Stage 3 or higher breast cancer
2. Any other concurrent malignancy including hematological malignancies
3. Baseline alopecia (defined CTCAE v4.0 grade >= 1)
4. Subjects with cold agglutinin disease or cold urticaria
5. Subjects who are scheduled for bone marrow ablation chemotherapy
6. Personal history of migraines, cluster or tension headaches
7. Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
8. Serum Albumin < 3.0 g/dL
9. Subjects with anemia (defined as a hemoglobin < 10 g/dL)
10. Abnormal TSH, AND:
If high, abnormal free T4 defined as out of normal limits
If low, abnormal free T4 or T3 defined as out of normal limits
11. Subjects who have diabetes with a Hgb A1c > 7%
12. Subjects who have lichen planus or lupus
13. Subjects who are underweight (defined as a BMI < 17.5)
14. Subjects who have had previous chemotherapy exposure
15.Subjects with difficulty of the proper cap fitting
16. Subjects with head injury or burn
17. Participation in any clinical trials at present or up to 30 days before consent acquisition.
18.Subjects with difficulty of complying with treatment regimen determined in the protocol
19.Life expectancy of subjects is expected less than 1 year.
20.Subjects determined to be ineligible by an investigator.
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kinoshita |
Organization
National Cancer Center Hospital
Division name
Department of Breast Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
takinosh@ncc.go.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Okamoto |
Organization
Century Medical,Inc.
Division name
Clinical Affairs Group
Zip code
141-8588
Address
1-11-2 Osaki, Shinagawa-ku, Tokyo 141-8588, Japan
TEL
03-3491-1552
Homepage URL
megumi_okamoto@cmi.co.jp
Sponsor or person
Institute
Century Medical,Inc.
Institute
Department
Personal name
Funding Source
Organization
Century Medical,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel
03-3542-2511
chiken_CT@ml.res.ncc.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Unpublished due to the article in submission
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished due to the article in submission
Number of participants that the trial has enrolled
58
Results
Unpublished due to the article in submission
Results date posted
| 2019 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished due to the article in submission
Participant flow
Unpublished due to the article in submission
Adverse events
Unpublished due to the article in submission
Outcome measures
Unpublished due to the article in submission
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041384
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