UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027892 |
|---|---|
| Receipt number | R000031959 |
| Scientific Title | Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2020/12/25 13:13:43 |
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Basic information
Public title
Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Acronym
Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Scientific Title
Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Scientific Title:Acronym
Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prevent chemotherapy-induced alopecia, use of a scalp cooling device is one of the most effective methods. All previous studies that used the Paxman Scalp Cooling System were carried out in Europe and United States where the patient's head shapes are quite different from those of Asians. In this study, we assess the effectiveness of a scalp cooling device in Japanese breast cancer patients who undergo adjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig]were considered to have hair preservation) at the end of 4 cycles of chemotherapy(TC or weekly PTX) by the physician in charge.
Key secondary outcomes
1.Wig or head cap use
2.Differences in success rates according to chemotherapy regimen
3.Safety assessment: Adverse events related to device use
4.Safety assessment: Head skin metastasis at 5 years later
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
1.Scalp cooling using the Paxman Scalp Cooling Device was done 30 minutes prior to, during and 90 minutes after each chemo therapy infusion.
2.Patients are instructed to perform gentler hair care than usual as much as possible at home.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.ECOG performance status 0 or 1
2.Adequate bone marrow,heart,liver and renal function
3.Informed consent is obtainable from the subject herself in documented form using the Consent Form
Key exclusion criteria
1.Previous chemotherapy treatment
2.Already have alopecia >grade 1 by CTCAE v4.0
3.History of migraine headaches, hypothyroidism, uncontrolled diabetes, and anorexia.
4.Any condition for contraindication of chemotherapy
5.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization)
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer
6.Difficulty to participate in this study due to mental illness or psychiatric symptoms
7.Any other reasons recognized as inadequate to participate in this study by doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruru |
| Middle name | |
| Last name | Kotani |
Organization
Aichi Cancer Center
Division name
Department of Breast Oncology
Zip code
464-8681
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL
052-762-6111
k.haruru@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Haruru |
| Middle name | |
| Last name | Kotani |
Organization
Aichi Cancer Center
Division name
Department of Breast Oncology
Zip code
464-8681
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL
052-762-6111
Homepage URL
k.haruru@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Aichi Cancer Center
Address
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
Tel
052-762-6111
k.haruru@aichi-cc.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 | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031959
