UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048637 |
|---|---|
| Receipt number | R000053280 |
| Scientific Title | Efficacy and safety study of PAXMAN and HairRepro MEDI Alpha for Chemotherapy Induced Alopecia for breast cancer |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2023/02/08 13:31:55 |
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Basic information
Public title
Efficacy and safety study of PAXMAN and HairRepro MEDI Alpha for Chemotherapy Induced Alopecia for breast cancer
Acronym
PAXMAN and HairRepro MEDI Alpha study
Scientific Title
Efficacy and safety study of PAXMAN and HairRepro MEDI Alpha for Chemotherapy Induced Alopecia for breast cancer
Scientific Title:Acronym
PAXMAN and HairRepro MEDI Alpha study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether the combination of Paxman and HairRepro MEDI alpha contributes to the prevention of chemotherapy-induced hair loss during adjuvant chemotherapy for breast cancer, whether it contributes to hair regrowth after hair loss, and whether it improves patient satisfaction as a result.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of improvement in alopecia 90 days after completion of chemotherapy based on imaging evaluation
Percentage of hair loss based on imaging evaluation at each observation point
Key secondary outcomes
Patient's quality of life:Chemotherapy-Induced Alopecia Distress Scale
Presence of adverse events
Tolerability: Percentage of patients who completed all cycles of chemotherapy while using both drugs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply HairRepro MEDI Alpha to the scalp and eyebrows twice a day, 4 ml per application.
A scalp cooling system (PAXMAN Scalp Cooling System) is applied to the head during chemotherapy, and cooling is performed from 30 minutes before to 90 minutes after treatment.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Breast cancer patient
2) Patient who have been decided to receive preoperative or postoperative chemotherapy
3) ECOG PS of 0 to 2
4) Patients with sufficient preservation of major organ function
5) Age: 20 years or older
6) Category of consultation: outpatient
7) Patients who agreed to the use of Paxman at their own expense
8) Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients with active multiple cancers
2) Patients with serious concomitant diseases (such as hepatic, renal, cardiac, hematological, or metabolic diseases) or psychiatric disorders
3) Patients who have been taking concomitantly banned drugs or study drugs within 4 weeks prior to the start of the study.
4) Patients with a history of allergy to Clozapine
5) Patients with eczema or other skin diseases on the head
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Fuji |
| Middle name | |
| Last name | Tsutomu |
Organization
University of Toyama
Division name
Department of Surgery and Science Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
076-434-7311
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Araki |
| Middle name | |
| Last name | Misato |
Organization
University of Toyama
Division name
Department of Surgery and Science Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
076-434-7311
Homepage URL
arammi33@med.u-toyama.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Faculty of Medicine,Academic Assembly, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Science, Faculty of Medicine,Academic Assembly, University of Toyama
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
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama City, Toyama Prefecture
Tel
076-415-8857
rinri@adm.u-toyama.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
富山大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 15 | 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
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053280
