Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients

Phase 2

• Conditions: Breast cancer

• Registration Number: JPRN-jRCTs042180065
• Lead Sponsor: Kotani Haruru

Brief Summary

The results including successful hair preservation rate and adverse events were consistent with previous reports.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1.ECOG performance status 0 or 1
2.Adequate bone marrow,heart,liver and renal function
3.Informed consent is obtainable from the subject herself in documented form using the Consent Form

Exclusion Criteria

1.Previous chemotherapy treatment
2.Already have alopecia >grade 1 by CTCAE v4.0
3.History of migraine headaches, hypothyroidism, uncontrolled diabetes, and anorexia.
4.Any condition for contraindication of chemotherapy
5.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization)
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer
6.Difficulty to participate in this study due to mental illness or psychiatric symptoms
7.Any other reasons recognized as inadequate to participate in this study by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig]were considered to have hair preservation) at the end of 4 cycles of chemotherapy(TC or weekly PTX) by the physician in charge.

Secondary Outcome Measures

Name	Time	Method
1.Wig or head cap use <br>2.Differences in success rates according to chemotherapy regimen <br>3.Safety assessment: Adverse events related to device use <br>4.Safety assessment: Head skin metastasis at 5 years later