NCT04190381

A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	FR-Mask	The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts. The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.

Timeline

• Start date: 2019-09-06
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2019-12-09
• Last updated: 2019-12-09

Locations

1 site across 1 country: Taiwan