The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy

The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy - The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029984

Enrollment

Registered

2017-11-20

Start date

2011-07-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

This study uses scalp-cooling equipment (Paxman cooler, U.K.) for about 180 minutes in the middle of receiving postoperative chemotherapy either AC(60/600 mg/m2) or TC(75/600 mg/m2).

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)primary breast cancer 2)Stage I or II 3)Patient underwent radical operation. 4)Patient scheduled to receive 4 cycles of postoperative adjuvant chemotherapy using either AC or TC. 5)Ages 20 years or more, less than 80 years. 6)ECOG performance status of 0,1 or 2. 7)Female 8)Required baseline laboratory parameters are as follows: Neutrophil count 1,500/mm3 or more Plt 100,00/mm3 or more AST and ALT less than 60 IU/L T-Bil less than 1.5mg/dL Cre less than 1.5mg/dL 9)Signed informed consent of the patient for registration.

Exclusion criteria

Exclusion criteria: 1)Any skin diseases 2)alopecia 3)history of radiation for head 4)allergy for doxorubicin, docetaxel, or cyclophosphamide 5)allergy for silicone 6)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 7)history of ischemic heart disease (angina pectoris or myocardial infarction) or cardiomyopathy 8)clinically significant infectious disease 9)history of interstitial pneumonia or pulmonary fibrosis 10)uncontrolled diabetes mellitus or under insulin treatment 11)the other malignant cancers 12)mental disease, or difficult-to-treat psychiatric patient 13)Raynaud's disease 14)Cold agglutinin disease 15)Cryoglobulinemia 16)Any other cases who are regarded as inadequate for study enrollment by the attending doctors

Design outcomes

Primary

Measure	Time frame
the proportion of patients which were able to complete 4 cycles of postoperative adjuvant AC or TC therapy in patients who used the scalp-cooling system	—

Secondary

Measure	Time frame
the degrees of comfort, satisfaction, the efficacy of hair loss prevention, the rates of adverse events, and the rates of metastases in patients who used the scalp-cooling system	—

Countries

Japan

Contacts

Public ContactSho Shiino

National Cancer Center Hospital Department of Breast Surgery

sshiino@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026