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

NCT07755553 | Completed

• 1 other identifier: HDT-RT-SKIN-2024-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis; Breast Cancer

Keywords

Breast Radiotherapy; Radiation-Induced Skin Reactions; Radiation Dermatitis; Skin Hydration; Skin Barrier Function; Erythema; Topical Cosmetic Formulation; Mushroom Extracts; Supportive Skin Care

Outcome Measures

Primary Outcomes (1)

• Change from baseline in skin hydration

  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.

  Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Participants with adverse events

  From first product application, approximately 15 days before radiotherapy, through 1 month after completion of radiotherapy

Study Arms (2)

Mushroom extract-containing topical cosmetic formulation

EXPERIMENTAL

Participants applied the investigational mushroom extract-containing topical cosmetic formulation to intact skin of the breast scheduled for irradiation twice daily. Application began approximately 15 days before radiotherapy, continued throughout the approximately 3-week radiotherapy period, and continued until 1 month after radiotherapy. Participants were instructed not to apply the formulation during the 3 to 4 hours before a radiotherapy session and not to use another cosmetic product on the study area.

Other: Mushroom extract-containing topical cosmetic formulation

Usual moisturizing cosmetic care

ACTIVE COMPARATOR

Participants used a moisturizing cosmetic product selected from products recommended as part of routine clinical practice. The product was applied to intact skin of the breast scheduled for irradiation 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 product during the 3 hours before radiotherapy and not to use another cosmetic product on the study area.

Other: Usual moisturizing cosmetic care

Interventions

Mushroom extract-containing topical cosmetic formulation OTHER

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.

Mushroom extract-containing topical cosmetic formulation

Usual moisturizing cosmetic care OTHER

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.

Usual moisturizing cosmetic care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hifas da Terra S.L.: lead
• AITEX Centro Investigación E Innovación: collaborator

Study Sites (1)

Hospital Universitario de San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms; Erythema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: November 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)