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Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00515762
Enrollment
150
Registered
2007-08-14
Start date
2007-05-31
Completion date
2010-06-30
Last updated
2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia, Breast Cancer

Keywords

persistent alopecia, docetaxel, breast cancer

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.

Interventions

DEVICEelasto-gel cap

scalp cooling cap

Sponsors

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
percentage of patients without persistent alopecia2nd year following docetaxel chemotherapy

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026