Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy

Phase 2

• Conditions: Breast cancer; D001943

• Registration Number: JPRN-jRCTs032180224
• Lead Sponsor: Karata Tomoko

Brief Summary

This study demonstrates that scalp cooling was an effective method of protection against hair loss caused bychemotherapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Patients stage 1,2,3 breast cancer

Exclusion Criteria

Patients who have malignant blood disease or scalp tumor or cold urticaria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful hair preservation assessed using the CTCAE4.0 scale during and after chemotherapy and device safety.

Secondary Outcome Measures

Name	Time	Method
Recovery status of hair loss after 3, 6, 9, 12 months from the end of chemotherapy.