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The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study

The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study - The Efficacy and Safety of Scalp Cooling Therapy for Patients with Gynecologic Malignancies: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056296
Enrollment
40
Registered
2025-01-01
Start date
2025-01-01
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

Gynecologic Malignancies

Interventions

None listed

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: If the following criteria are met, the attending physician will confirm eligibility on the case registration form and proceed with enrollment: Diagnosis of a gynecologic malignancy cervical cancer, endometrial cancer, or ovarian cancer. Radical surgery has been performed. Six cycles of TC or TCBEV therapy are planned as postoperative adjuvant chemotherapy. Aged 20 years or older and under 80 years. Performance Status 0 - 2. Major organ functions are preserved. Patient is willing to undergo anticancer therapy combined with scalp cooling therapy. Written informed consent for participation in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: (1) Skin diseases on the scalp (2) Alopecia (especially male-generated alopecia) (3) History of treatment with head radiation therapy (4)Allergy to Paclitaxel or Carboplatin (5) Allergy to silicone (6) Pregnant, lactating, may be pregnant, or intend to become pregnant (7) Ischemic heart disease (angina pectoris or myocardial infarction), concomitant cardiomyopathy, or history of cardiomyopathy (8) Has an active infection (9) Interstitial pneumonia or pulmonary fibrosis (10) Poorly controlled diabetes mellitus (HbA1c(NGSP) > 10.0%) (11) Concurrent overlapping cancers

Design outcomes

Primary

MeasureTime frame
The effect of hair loss prevention after six courses of TC or TCBEV therapy combined with scalp cooling therapy following radical surgery in patients with gynecologic malignancies.

Countries

Japan

Contacts

Public ContactSHINYA OKI

Keio University School of Medicine Department of Obstetrics and Gynecology

ooki@keio.jp03-3353-1211

Outcome results

None listed

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