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Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515762
First Posted: August 14, 2007
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital San Carlos, Madrid
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Miguel Martin, MD, Hospital San Carlos
ClinicalTrials.gov Identifier: NCT00515762     History of Changes
Other Study ID Numbers: ALOPER-2
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: August 9, 2011
Last Verified: June 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Alopecia
Alopecia Areata
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action