Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Changes in skin quality [Time frame: Up to 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06401889 · MC220302 · 22-002971