Clinical trial NCT04035408: Facial Skin Health Tracking Feasibility in Breast Cancer Patients
Official title: Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer Female
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our baseline skin health self-assessment tool accounts for smoking status, sun exposure, and sunscreen use and this will factor into our assessments/comparison to age and ethnicity matched norms. Sun exposure will likely affect skin age differences at baseline but should not affect the skin aging over the duration of the study.

Brief summary: This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

Detailed description: There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.

Eligibility criteria: Inclusion Criteria:

1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a pre or perimenopausal woman age 18 or over
4. Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment

Exclusion Criteria:

1. Postmenopausal status (one year without a menstrual period)
2. Pregnant women (pregnancy test not required)
3. Prior cancer diagnosis of any type other than breast cancer
4. History of prior treatment with chemotherapy or radiation therapy
5. Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
6. Use of a retinoid-based prescription facial skin product within the past 11 month

Primary outcomes:
measure: Percentage of compliance in each of the 4 assessment tools
timeFrame: 3 years
Secondary outcomes:
measure: Changes in skin health over the duration of the study (4 assessment points)
timeFrame: 3 years
measure: Changes in body image / skin QOL at end of treatment compared to baseline
timeFrame: 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: