Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

This study has been completed.
Sponsor:
Information provided by:
Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT00515762
First received: August 13, 2007
Last updated: August 8, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Alopecia
Breast Cancer
Device: elasto-gel cap
Phase 2

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


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 ]

Enrollment: 150
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: scalp cooling
scalp cooling
Device: elasto-gel cap
scalp cooling cap
Other Name: elasto-gel cap

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Hospital Clinico San Carlos
Madrid, Spain, 28040
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: Miguel Martin, MD, Hospital San Carlos
ClinicalTrials.gov Identifier: NCT00515762     History of Changes
Other Study ID Numbers: ALOPER-2
Study First Received: August 13, 2007
Last Updated: August 8, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital San Carlos, Madrid:
persistent alopecia
docetaxel
breast cancer

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Breast Neoplasms
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Neoplasms by Site
Neoplasms
Breast Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014