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Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

Primary Purpose

Alopecia, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
elasto-gel cap
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alopecia focused on measuring persistent alopecia, docetaxel, breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1: scalp cooling

Arm Description

scalp cooling

Outcomes

Primary Outcome Measures

percentage of patients without persistent alopecia

Secondary Outcome Measures

Full Information

First Posted
August 13, 2007
Last Updated
August 8, 2011
Sponsor
Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT00515762
Brief Title
Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling
Official Title
Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital San Carlos, Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Breast Cancer
Keywords
persistent alopecia, docetaxel, breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: scalp cooling
Arm Type
Experimental
Arm Description
scalp cooling
Intervention Type
Device
Intervention Name(s)
elasto-gel cap
Intervention Description
scalp cooling cap
Primary Outcome Measure Information:
Title
percentage of patients without persistent alopecia
Time Frame
2nd year following docetaxel chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
miguel martin, MD, PHD
Organizational Affiliation
hospital clinico san carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29923063
Citation
Martin M, de la Torre-Montero JC, Lopez-Tarruella S, Pinilla K, Casado A, Fernandez S, Jerez Y, Puente J, Palomero I, Gonzalez Del Val R, Del Monte-Millan M, Massarrah T, Vila C, Garcia-Paredes B, Garcia-Saenz JA, Lluch A. Persistent major alopecia following adjuvant docetaxel for breast cancer: incidence, characteristics, and prevention with scalp cooling. Breast Cancer Res Treat. 2018 Oct;171(3):627-634. doi: 10.1007/s10549-018-4855-2. Epub 2018 Jun 19. Erratum In: Breast Cancer Res Treat. 2018 Jul 16;:
Results Reference
derived

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Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

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