Enhancing Skin Appearance and Quality of Life in Breast C... | NCT06401889

Studies
Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

NCT06401889

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Adenocarcinoma
Estrogen Receptor-Positive Breast Carcinoma
Progesterone Receptor-Positive Breast Carcinoma

Interventions

Non-Interventional Study

Countries

United States

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

ID	Type	Description	Link
22-002971	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2024Actual

Primary Completion Date

Jul 19, 2027Estimated

Completion Date

Jul 19, 2027Estimated

First Submitted Date

May 2, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 7, 2024Actual

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

May 18, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy.

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the incidence and severity of skin quality changes after initiation of Aromatase Inhibitor (AI) therapy in breast cancer (BC) survivors through use of Canfield Sciences VISIA-CA technology and facial skin assessment photography.

II. Evaluate impact of AI therapy on patient-reported self-esteem and dermatology related life quality through validated patient reported outcome measures.

III. Assess for objective improvements in skin quality measurements with VISIA-CA after skincare intervention with aesthetician consultation.

IV. Measure changes in patient-reported self-esteem and dermatology related life quality following skincare intervention.

OUTLINE: This is an observational study.

Patients complete surveys/questionnaires, undergo skin measurement with the VISIA CA device, undergo facial skin photography, and attend consultations with an aesthetician on study.

Conditions Module

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Adenocarcinoma
Estrogen Receptor-Positive Breast Carcinoma
Progesterone Receptor-Positive Breast Carcinoma

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients complete surveys/questionnaires, undergo skin measurement with the VISIA CA device, undergo facial skin photography, and attend consultations with an aesthetician on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in skin quality	Changes in skin quality measured as incidence and severity of skin quality changes using VISIA-CA technology (skin analysis imaging system) and facial skin assessment photography.	Up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

* Female ≥ 18 years
- Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion
- Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and/or progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2)
- Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included
- Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period
- Willing and able to provide consent

Exclusion Criteria:

* Patients who have previously taken AIs
- Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women 18 years or older with diagnosis of estrogen receptor (ER) positive breast cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Referral Office	Contact	855-776-0015		mayocliniccancerstudies@mayo.edu

Overall Officials

Name	Affiliation	Role
Leila M. Tolaymat, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida	Recruiting	Jacksonville	Florida	32224-9980	United States

ID	Term
D002278	Carcinoma in Situ
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases