Breast Cancer Clinical Trial
Official title:
A Single-arm, Open Label, Single Center Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy
The breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and
death and is widely used for standard treatment for breast cancer. However, radiation
dermatitis is a major adverse event of breast radiotherapy. Radiation-irritated skin is a
treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin
structure and causes a variety of symptoms of cuticle thinning, sweat glands damage,
sebaceous glands damage and basal membrane damage. Radiation-irritated skin also leads to
lost work productivity, wound care costs, social isolation and altered body image. Thus,
radiation-irritated skin can greatly impact the quality of life.
Several studies have examined the effects of numerous topical agents to reduce the dryness of
skin. However, the reported results have not been clinically significant. Previous studies
have shown that deer antler velvet extract possess inflammatory function and repair damaged
follicles, sweat glands and sebaceous gland. And biocellulose membrane is a highly efficient
media to introduce velvet extract to damaged skin tissue.
In this study, velvet extract combined with biocellolose membrane will be used in breast
cancer patients to test the safety and efficacy to alleviate their radiation-irritated skin
symptoms.
The investigational medical product of this study is a biomedical repair mask, FR-MASK ;the
formula of FR-Mask is deer antler velvet, which is a traditional Chinese tonic medicine
combined with high-adhesion biocellulose membrane.
The primary objective of this study is to test the safety and clinical outcomes of FR-Mask
application in breast cancer patients who have radiation-irritated skin due to the
post-operative radiotherapy.
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