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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401889
• Other study ID #: MC220302
• Secondary ID: NCI-2024-0346822
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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