Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy (NCT07755553) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Mushroom Extract-Containing Topical Cosmetic Formulation During Breast Radiotherapy
Spain50 participantsStarted 2024-11-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in skin hydration
Timeframe: Baseline, approximately 15 days before radiotherapy; start of radiotherapy; end of radiotherapy, approximately Day 21; and 1 month after radiotherapy