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

NCT06401889 | Recruiting

• 2 other identifiers: MC22030222-002971
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \* 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leila M. Tolaymat, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): July 19, 2027
• Study Completion (Estimated): July 19, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)