Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy

This was a prospective, randomized, parallel-group study conducted in women aged 18 to 75 years who were scheduled to receive breast radiotherapy after breast-conserving surgery.

Participants were assigned to one of two groups. The investigational group used a multi-ingredient topical cosmetic formulation containing extracts of Cordyceps sinensis, Ganoderma lucidum, and Hericium erinaceus, together with moisturizing and skin-conditioning ingredients. The control group used a moisturizing cosmetic product selected from products recommended as part of routine clinical practice.

In both groups, the assigned cosmetic product was applied topically to intact skin of the breast scheduled for irradiation twice daily. Application began approximately 15 days before the start of radiotherapy, continued during the approximately 3-week radiotherapy period, and continued until 1 month after completion of radiotherapy. Participants were instructed not to apply the product during the 3 to 4 hours before radiotherapy and not to use another cosmetic product on the study area during the study.

Assessments were performed at four time points: approximately 15 days before radiotherapy, at the start of radiotherapy, at the end of radiotherapy, and 1 month after radiotherapy. Skin hydration was measured using a Corneometer, transepidermal water loss was measured using a Tewameter, and erythema and pigmentation were measured using a Mexameter. Measurements were obtained from predefined areas of the irradiated breast. Dermatologic assessments, clinical evaluation of skin reactions, standardized photographs, participant questionnaires, and adverse-event monitoring were also performed.

The study was designed to compare changes in skin hydration, skin barrier function, erythema, pigmentation, clinical skin reactions, and participant-reported skin comfort between the investigational cosmetic formulation and usual cosmetic skin care.

Inclusion criteria

• Female sex.
• Age 18 to 75 years.
• Scheduled to begin breast radiotherapy following breast-conserving surgery.

Exclusion criteria

• Contraindication to radiotherapy.
• History of allergic reactions to any component of the assigned cosmetic product.
• Use of topical medications or creams on the product application area during the 7 days before starting the assigned cosmetic product.
• Hypersensitivity or sensitivity in the area scheduled for irradiation.
• Any disease or disorder that, in the investigator's opinion, could interfere with the evaluation of safety or efficacy.
• Chronic or currently active skin disease that, in the investigator's opinion, could adversely affect skin condition following radiotherapy.
• History of organ removal or organ transplantation.
• Immunodeficiency.
• Progressive febrile condition.
• Use of topical or systemic treatments that could interfere with evaluation of the assigned cosmetic product.