Prevention of Persistent Alopecia Following Docetaxel by... | NCT00515762

Studies
Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

NCT00515762

Sponsor

Hospital San Carlos, Madrid

Status

Completed

Last Update Posted

Aug 9, 2011Estimated

Enrollment

150Actual

Phase

Phase 2

Conditions

Alopecia
Breast Cancer

Interventions

elasto-gel cap

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2011

Last Update Posted Date

Aug 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: scalp cooling	Experimental	scalp cooling	Device: elasto-gel cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
elasto-gel cap	Device	scalp cooling cap	1: scalp cooling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients without persistent alopecia		2nd year following docetaxel chemotherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
miguel martin, MD, PHD	hospital clinico san carlos	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos		Madrid	Madrid	28040	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29923063	Derived	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.

ID	Term
D000505	Alopecia
D001943	Breast Neoplasms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases