Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling
- Conditions
- AlopeciaBreast Cancer
- Interventions
- Device: elasto-gel cap
- Registration Number
- NCT00515762
- Lead Sponsor
- Hospital San Carlos, Madrid
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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)
- contraindications for adjuvant docetaxel and or anthracyclines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1: scalp cooling elasto-gel cap scalp cooling
- Primary Outcome Measures
Name Time Method percentage of patients without persistent alopecia 2nd year following docetaxel chemotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Clinico San Carlos
🇪🇸Madrid, Spain