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NCT00515762 Clinical Trial

Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

Breast Cancer Clinical Trial

Official title:
Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515762
Other study ID # ALOPER-2
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2007
Last updated August 8, 2011
Start date May 2007
Est. completion date June 2010

Study information
Verified date June 2010
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 150
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• elasto-gel cap
scalp cooling cap

Locations
Country Name City State
Spain Hospital Clinico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of patients without persistent alopecia 2nd year following docetaxel chemotherapy Yes
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