UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026955 |
|---|---|
| Receipt number | R000028812 |
| Scientific Title | Trial of the efficacy and safety of CG428 lotion against the adjuvant chemotherapy induced alopecia in breast cancer patients. |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2019/10/14 17:08:01 |
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Basic information
Public title
Trial of the efficacy and safety of CG428 lotion against the adjuvant chemotherapy induced alopecia in breast cancer patients.
Acronym
ALOBRCA
Scientific Title
Trial of the efficacy and safety of CG428 lotion against the adjuvant chemotherapy induced alopecia in breast cancer patients.
Scientific Title:Acronym
ALOBRCA
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy, safety and QOL of topical lotion CG428 in the breast cancer patients against chemotherapy alopecia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the rate of candidates who could take off their wig at twelve months after chemotherapy ends.
Key secondary outcomes
duration of chemotherapy alopecia
symptoms(itching, pain of the skin)
nail change
AE
assessment using Olsen/Canfield visual analog scale
HRQOL
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
| Other |
Interventions/Control_1
Start using CG428 before the beginning of (neo)adjuvant 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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) pathologically proven breast cancer
2) patients who are planned to receive anthracyclin and taxman regimen (neo)adjuvant chemotherapy. Trastuzumab usage is not restricted.
3) ECOG Performance status (PS) 0-2
4) Able to give written informed consent.
Key exclusion criteria
1) Known allergy or hypersensitivity to some components of CG428.
2) Patients with recent (within 3 months) usage of other anti-hair-loss treatments.
3) Previous use of other anti-hair-loss treatment or hair growth treatment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kojima |
Organization
St.Marianna University School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
216-8511
Address
2-16-1 Miyamae-ku, Sugao, Kawasaki, Kanagawa
TEL
044-977-8111
kojiyasu@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kojima |
Organization
St.Marianna University School of Medicine
Division name
Breast and Endocrine Surgery
Zip code
216-8511
Address
2-16-1 Miyamae-ku, Sugao, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
kojiyasu@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
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
St.Marianna University School of Medicine, Seimei-rinri committee
Address
2-16-1 Miyamae-ku, Sugao, Kawasaki, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2017 | Year | 04 | Month | 11 | 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
64
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2019 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028812
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
