Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a special chest dressing called FR-101 to help prevent skin problems caused by radiation therapy in women with breast cancer. Radiation therapy is a common treatment for breast cancer, but it can lead to a painful skin condition known as radiation dermatitis, which can affect a patient’s quality of life during and after treatment. The study aims to see if using the FR-101 dressing can reduce the severity of this skin condition for patients undergoing radiation therapy.

To participate in this trial, individuals must be at least 20 years old and have been diagnosed with certain types of breast cancer. They should be scheduled for radiation therapy following surgery. Participants will apply the FR-101 dressing to the affected skin area every two days during their treatment and will need to visit the clinic regularly for check-ups to monitor their skin's condition. The entire study will last for about three months. It's important to note that some individuals may not be eligible due to certain health conditions or previous treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be males or non-pregnant females at least 20 years of age.
• • Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
• • Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy.
• • Participant must give informed consent.
• Exclusion Criteria:
• • Bilateral breast cancer
• • Previous radiotherapy to the chest
• • Chemotherapy concurrent with radiation treatment
• • Prior breast reconstructions, implants, and/or expanders
• • Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
• • Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
• • Participation in any clinical trial in the prior 30 days from baseline.
• • Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.