NCT01459003

Brief Summary

Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3 breast-cancer

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

October 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

October 24, 2011

Last Update Submit

May 5, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • quality of life questionnaire

    body image

    up to 12 months

Study Arms (2)

experimental

EXPERIMENTAL
Other: beauty care

control

NO INTERVENTION

Interventions

beauty careOTHER

beauty care performed before each chemo cycle

experimental

Eligibility Criteria

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

You may qualify if:

  • breast cancer with no metastasis receiving adjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Related Publications (1)

  • Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2022 Mar;31(3):723-732. doi: 10.1007/s11136-021-02947-6. Epub 2021 Jul 29.

    PMID: 34324138DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mahasti Saghatchian, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

FR(1)