NCT06401889Recruiting

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

Mayo Clinic

Start Date

7/19/2024

Completion Date

7/19/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Non-Interventional Study

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Conditions

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast AdenocarcinomaEstrogen Receptor-Positive Breast CarcinomaProgesterone Receptor-Positive Breast Carcinoma

Locations

Mayo Clinic in Florida

Jacksonville, Florida 32224-9980

United States