NCT00515762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 9, 2011

Status Verified

June 1, 2010

Enrollment Period

3.1 years

First QC Date

August 13, 2007

Last Update Submit

August 8, 2011

Conditions

AlopeciaBreast Cancer

Keywords

persistent alopeciadocetaxelbreast cancer

Outcome Measures

Primary Outcomes (1)

  • percentage of patients without persistent alopecia

    2nd year following docetaxel chemotherapy

Study Arms (1)

1: scalp cooling

EXPERIMENTAL

scalp cooling

Device: elasto-gel cap

Interventions

elasto-gel capDEVICE

scalp cooling cap

1: scalp cooling

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • contraindications for adjuvant docetaxel and or anthracyclines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29923063DERIVED

MeSH Terms

Conditions

AlopeciaBreast Neoplasms

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast Diseases

Study Officials

  • miguel martin, MD, PHD

    hospital clinico san carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 9, 2011

Record last verified: 2010-06

Locations

ES(1)