Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

Hospital San Carlos, Madrid150 enrolled

Overview

Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Alopecia Breast Cancer

Interventions

elasto-gel capDEVICE

scalp cooling cap

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18-75 * breast cancer stages II-III * adjuvant or neoadjuvant chemotherapy with docetaxel regimens (TAC or anthracyclines followed by docetaxel 100 mg/m2 x 4) Exclusion Criteria: * contraindications for adjuvant docetaxel and or anthracyclines

Locations (1)

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

percentage of patients without persistent alopecia

Time frame: 2nd year following docetaxel chemotherapy

Data from ClinicalTrials.gov

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