Breast Cancer, Radiation Dermatitis
Conditions
Keywords
Breast Radiotherapy, Radiation-Induced Skin Reactions, Radiation Dermatitis, Skin Hydration, Skin Barrier Function, Erythema, Topical Cosmetic Formulation, Mushroom Extracts, Supportive Skin Care
Brief summary
This study evaluated a mushroom extract-containing topical cosmetic formulation for skin care in women receiving radiotherapy to the breast after breast-conserving surgery. Participants were randomly assigned to use either the investigational cosmetic formulation or usual moisturizing cosmetic care. The assigned cosmetic product was applied to intact skin of the breast twice daily, beginning approximately 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. Participants were instructed not to apply the cosmetic product during the 3 to 4 hours before a radiotherapy session. Skin condition was assessed before use of the assigned product, at the start and end of radiotherapy, and 1 month after radiotherapy. Assessments included skin hydration, transepidermal water loss, erythema, pigmentation, dermatologic evaluation, photographs, participant-reported product experience, and adverse events. The study compared changes over time between the investigational formulation and usual cosmetic skin care.
Detailed description
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.
Interventions
OTHERMushroom extract-containing topical cosmetic formulation
A multi-ingredient topical cosmetic cremigel containing extracts of Cordyceps sinensis, Ganoderma lucidum, and Hericium erinaceus, together with moisturizing and skin-conditioning ingredients. Participants applied the required amount with a gentle massage to intact skin of the breast twice daily, beginning approximately 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. The formulation was not applied during the 3 to 4 hours before a radiotherapy session. No other cosmetic product was permitted on the study area.
OTHERUsual moisturizing cosmetic care
A nonstandardized moisturizing cosmetic product selected by the participant from products recommended by the clinical staff as part of routine skin care during breast radiotherapy. Participants applied the selected product to intact skin of the breast twice daily, beginning approximately 15 days before radiotherapy, continuing throughout the approximately 3-week radiotherapy period, and ending 1 month after radiotherapy. The product was not applied during the 3 hours before a radiotherapy session. No other cosmetic product was permitted on the study area.
Sponsors
Hifas da Terra S.L.
AITEX Centro Investigación E Innovación
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and the principal investigator were aware of the assigned cosmetic regimen. Dermatologic and instrumental outcome assessments were performed by evaluators who were intended to remain unaware of treatment allocation. The same dermatologist performed the dermatologic assessments, and the same trained evaluator performed the instrumental measurements throughout the study.
Intervention model description
Participants were randomized in a 1:1.5 ratio to one of two parallel groups: a mushroom extract-containing topical cosmetic formulation or usual moisturizing cosmetic care. Both groups used their assigned topical cosmetic regimen from approximately 15 days before breast radiotherapy until 1 month after completion of radiotherapy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in skin hydration | Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy | Skin hydration of the irradiated breast was measured in arbitrary units using the Corneometer® CM 825. Measurements were obtained from predefined breast regions. The outcome was the change from baseline and the trajectory of skin hydration over the study visits. Higher values indicate greater stratum corneum hydration. Changes over time were compared between the mushroom extract-containing topical cosmetic formulation and usual moisturizing cosmetic care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in transepidermal water loss | Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy | Transepidermal water loss was measured at the nipple-areola complex in g/m²/h using the Tewameter® TM 300. The outcome was the change from baseline and the trajectory over the study visits. Lower values indicate less water loss and better skin barrier function. |
| Change from baseline in skin erythema index | Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy | Erythema of the irradiated breast skin was measured in index units using the Mexameter® MX 18 at predefined breast regions. The outcome was the change from baseline and the trajectory over the study visits. Higher values indicate greater erythema. |
| Change from baseline in skin melanin index | Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy | Skin pigmentation of the irradiated breast was measured in melanin index units using the Mexameter® MX 18 at predefined breast regions. The outcome was the change from baseline and the trajectory over the study visits. Higher values indicate greater pigmentation. |
| Severity of radiation-induced skin reactions | Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy | Skin reactions in the irradiated breast were evaluated clinically and categorized as: 0, no reaction; 1, mild erythema; 2, moderate radiodermatitis; or 3, severe or mixed reaction. The distribution of severity categories was compared between the two study groups at each assessment. |
| Participants with adverse events | From first product application, approximately 15 days before radiotherapy, through 1 month after completion of radiotherapy | Number and percentage of participants who experienced any adverse event or undesirable local skin reaction after starting the assigned cosmetic regimen. Events were reported by participants and evaluated by the investigators for severity and relationship to the assigned cosmetic regimen. |
| Participant-reported product experience | End of radiotherapy, approximately Day 21, and 1 month after completion of radiotherapy | Participants assigned to the investigational formulation completed a product-use questionnaire containing 8 numerical items scored from 1 to 5 and 1 open-comment item. A score of 1 represented the most unfavorable response or strong disagreement, and a score of 5 represented the most favorable response or strong agreement. Items assessed application comfort, absorption, post-application comfort, perceived hydration, calming of itching or stinging, perceived redness, general well-being, and overall product rating. Item-level scores were summarized; no validated total score was defined. |
Countries
Spain
Outcome results
None listed