NCT04180579

Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.

Conditions

• Breast Cancer
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
DEVICE	PAXMAN Scalp Cooler	Scalp cooling will occur with each dose of chemotherapy.

Timeline

• Start date: 2019-11-26
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2019-11-27
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study