Unique ID issued by UMIN | UMIN000048583 |
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Receipt number | R000055318 |
Scientific Title | Follow-up of the efficacy of topical CG428 for chemotherapy-induced nail damage in breast cancer patients undergoing adjuvant chemotherapy. |
Date of disclosure of the study information | 2022/08/12 |
Last modified on | 2023/08/04 11:28:31 |
Follow-up of the efficacy of topical CG428 for chemotherapy-induced nail damage in breast cancer patients undergoing adjuvant chemotherapy.
Follow-up of the efficacy of CG428 on nail disorders in breast cancer patients undergoing chemotherapy
Follow-up of the efficacy of topical CG428 for chemotherapy-induced nail damage in breast cancer patients undergoing adjuvant chemotherapy.
Follow-up of the efficacy of CG428 on nail disorders in breast cancer patients undergoing chemotherapy
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To determine whether CG428 is effective in the early recovery of nail damage caused by adjuvant chemotherapy for breast cancer
Efficacy
Time to cure of nail symptoms(Before the start of chemotherapy, after completion of 1 regimen, after completion of 2 regimens, and 3, 6, 9, and 12 months after completion of chemotherapy)
Assessment of morbidity of nail symptoms, and quality of life related to nail symptoms(Before the start of chemotherapy, after completion of 1 regimen, after completion of 2 regimens, and 3, 6, 9, and 12 months after completion of chemotherapy)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Use of topical formulation CG428
CG428 is applied to all nails on both hands and feet twice daily, morning and evening, using a brush to apply CG428 from the nail to the skin around the nail. Using CG428 is continued for up to 1 year after completion of chemotherapy.
20 | years-old | <= |
75 | years-old | >= |
Female
1. Patients with Stage I-III primary breast cancer diagnosed histologically at Nagasaki Harbor Medical Center between July 1, 2022 and June 30, 2024.
2. Patients with primary breast cancer who are planned to receive an anthracycline and a taxane, or a taxane and a platinum-based therapy, or a taxane-based therapy as preoperative or postoperative adjuvant therapy. (Use of trastuzumab or pertuzumab is not restricted.
3. Patients who have been fully informed about their participation in the study and who have given their free and voluntary consent based on their full understanding of the study.
1. Patients undergoing chemotherapy treatment for other diseases
2. Patients with pre-treatment nail symptoms
3. Patients receiving any kind of treatment for nail symptoms
4. Patients with a history of hypersensitivity to ingredients of topical agents (e.g. ethanol), cosmetics, hair growth products, etc.
5. Other patients deemed inappropriate as research subjects by the investigators
40
1st name | Chika |
Middle name | |
Last name | Sakimura |
Nagasaki Harbor Medical Center
Dept. of Breast and Endocrine Surgery
850-8555
6-39 Shinchi-machi, Nagasaki, JAPAN
095-822-3251
c_sakimur@icloud.com
1st name | Toshinobu |
Middle name | |
Last name | Ina |
Nagasaki Harbor Medical Center
Innovation and Translational Research Center
850-8555
6-39 Shinchi-machi, Nagasaki, JAPAN
095-822-3251
kenkyu-ml@ncho.jp
Nagasaki Harbor Medical Center
None
Other
Nagasaki Harbor Medical Center
6-39 Shinchi-machi, Nagasaki, JAPAN
095-822-3251
kenkyu-ml@ncho.jp
NO
2022 | Year | 08 | Month | 12 | Day |
Unpublished
Preinitiation
2022 | Year | 06 | Month | 28 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 08 | Month | 15 | Day |
2025 | Year | 12 | Month | 31 | Day |
2022 | Year | 08 | Month | 04 | Day |
2023 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055318
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