Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

This study is currently recruiting participants.

Verified by Hospital San Carlos, Madrid, May 2008

First Received: August 13, 2007 Last Updated: May 14, 2008 History of Changes

Sponsor:	Hospital San Carlos, Madrid
Information provided by:	Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT00515762

Purpose

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.

Condition	Intervention	Phase
Alopecia Breast Cancer	Device: elasto-gel cap	Phase II

Study Type:	Interventional
Study Design:	Prevention, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hair Problems

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:

percentage of patients without persistent alopecia [ Time Frame: 2nd year following docetaxel chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: scalp cooling: Experimental scalp cooling	Device: elasto-gel cap scalp cooling cap

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515762

Contacts

Contact: miguel martin, MD, PHD

+34-91-3303000 ext 3545

mmartin@geicam.org

Locations

Spain
Hospital Clinico San Carlos	Recruiting
madrid, Spain, 28040
Contact: miguel martin, MD, PHD +34-91-3303000 ext 3546 mmartin@geicam.org
Principal Investigator: miguel martin, MD, PHD

Sponsors and Collaborators

Hospital San Carlos, Madrid

Investigators

Principal Investigator:

miguel martin, MD, PHD

hospital clinico san carlos

More Information

No publications provided

Responsible Party:	Hospital San Carlos ( Miguel Martin, MD )
Study ID Numbers:	ALOPER-2
Study First Received:	August 13, 2007
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00515762 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital San Carlos, Madrid:

persistent alopecia
docetaxel
breast cancer

Additional relevant MeSH terms:

Hair Diseases
Pathological Conditions, Anatomical
Hypotrichosis
Skin Diseases
Antineoplastic Agents
Breast Neoplasms
Pharmacologic Actions

Docetaxel
Neoplasms
Neoplasms by Site
Alopecia
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 30, 2009