UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048583
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

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Basic information

Public title

Follow-up of the efficacy of topical CG428 for chemotherapy-induced nail damage in breast cancer patients undergoing adjuvant chemotherapy.

Acronym

Follow-up of the efficacy of CG428 on nail disorders in breast cancer patients undergoing chemotherapy

Scientific Title

Follow-up of the efficacy of topical CG428 for chemotherapy-induced nail damage in breast cancer patients undergoing adjuvant chemotherapy.

Scientific Title:Acronym

Follow-up of the efficacy of CG428 on nail disorders in breast cancer patients undergoing chemotherapy

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine whether CG428 is effective in the early recovery of nail damage caused by adjuvant chemotherapy for breast cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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)

Key secondary outcomes

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)


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

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.

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

75 years-old >=

Gender

Female

Key inclusion criteria

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.

Key exclusion criteria

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

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Chika
Middle name
Last name Sakimura

Organization

Nagasaki Harbor Medical Center

Division name

Dept. of Breast and Endocrine Surgery

Zip code

850-8555

Address

6-39 Shinchi-machi, Nagasaki, JAPAN

TEL

095-822-3251

Email

c_sakimur@icloud.com


Public contact

Name of contact person

1st name Toshinobu
Middle name
Last name Ina

Organization

Nagasaki Harbor Medical Center

Division name

Innovation and Translational Research Center

Zip code

850-8555

Address

6-39 Shinchi-machi, Nagasaki, JAPAN

TEL

095-822-3251

Homepage URL


Email

kenkyu-ml@ncho.jp


Sponsor or person

Institute

Nagasaki Harbor Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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

Nagasaki Harbor Medical Center

Address

6-39 Shinchi-machi, Nagasaki, JAPAN

Tel

095-822-3251

Email

kenkyu-ml@ncho.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

2022 Year 08 Month 12 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

Preinitiation

Date of protocol fixation

2022 Year 06 Month 28 Day

Date of IRB

2022 Year 07 Month 20 Day

Anticipated trial start date

2022 Year 08 Month 15 Day

Last follow-up date

2025 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 04 Day

Last modified on

2023 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name