Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

San Carlos Clinical Hospital

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Alopecia

Treatments: Device: elasto-gel cap

Study type: Interventional

Funder types: Other

Identifiers

NCT00515762

ALOPER-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

1: scalp cooling

Experimental group

Description:

scalp cooling

Treatment:

Device: elasto-gel cap