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

Recruiting

• 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: Other: Non-Interventional Study

• Registration Number: NCT06401889
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Study Start: 2024-07-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Changes in skin quality	Up to 6 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States