Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
18 Years
75 Years
Female
Alopecia, Breast Cancer
Trial Information
Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
percentage of patients without persistent alopecia
Outcome Time Frame:
2nd year following docetaxel chemotherapy
Safety Issue:
Yes
Principal Investigator
miguel martin, MD, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
hospital clinico san carlos
Authority:
Spain: Spanish Agency of Medicines
Study ID:
ALOPER-2
NCT ID:
NCT00515762
Start Date:
May 2007
Completion Date:
June 2010
Related Keywords:
- Alopecia
- Breast Cancer
- persistent alopecia
- docetaxel
- breast cancer
- Alopecia
- Alopecia Areata
- Breast Neoplasms
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