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Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy

Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy - Hair loss restraint by scalp cooling enforcement (Scalp cooling study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031534
Enrollment
120
Registered
2018-03-01
Start date
2018-04-01
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 device (Paxman cooler, U.K.) for about 180 minutes during receiving chemotherapy.(30 minutes before and 90 minutes after chemotherapy)

Sponsors

National Hospital Organization Kyushu Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Histologically confirme breast cancer 2)Stage I, II or III 3)Female aged 20 to 75 years old. 4)The case for that is planned anthracycline, taxane-based chemotherapy and in that hair loss is expected. 5)No history of the chemotherapy for the malignant tumor 6)Signed informed consent of the patient for registration.

Exclusion criteria

Exclusion criteria: 1)Chilly allergy 2)Cold agglutinin disease 3)Any scalp skin tumor 4)History of radiation for head 5)Temporomandibular disorder or disease to a chin 6)Any other cases who are regarded as inadequate for study enrollment by the attending doctors

Design outcomes

Primary

MeasureTime frame
Rate of grade 0 or 1 of hair loss, according to CTCAE ver4.0 classification

Secondary

MeasureTime frame
Rate of hair loss restraint in each evaluation timing Hair loss accompanying symptom Hair loss period Safety Adverse events Influence of the hair loss after the chemotherapy

Countries

Japan

Contacts

Public ContactChinami Koga

National Hospital Organization Kyushu Cancer Center Breast Oncology

koga.chinami.qb@mail.hosp.go.jp092-541-3231

Outcome results

None listed

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