Phase I-II Clinical Study of Taurine for External Use in the Prevention and Treatment of Acute Radiation Skin Injury

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Acute radiation skin injury is the most common side effect of radiation therapy in patients with chest tumors, which can be manifested as erythema, dry peeling, wet peeling, and severe ulcers. Even with current advanced radiotherapy techniques, such as intensity-modulated reverse radiation therapy (IMRT), about one-third of patients develop grade 2 or higher skin damage during radiotherapy. Radiation skin damage can cause discomfort to patients, thus affecting their daily life and reducing their quality of life. In severe cases, it can even reduce the efficacy due to prolonged treatment time. Therefore, prevention and treatment of acute radiation skin injury is a difficult problem to be solved urgently in clinical practice. Even with current advanced radiotherapy techniques, such as intensity-modulated reverse radiation therapy (IMRT), about one-third of patients develop grade 2 or higher skin damage during radiotherapy. Radiation skin damage can cause discomfort to patients, thus affecting their daily life and reducing their quality of life. In severe cases, it can even reduce the efficacy due to prolonged treatment time. Therefore, prevention and treatment of acute radiation skin injury is a difficult problem to be solved urgently in clinical practice. From previous studies, we found that taurine is an active substance that regulates normal physiological activities of the body and is widely distributed in various tissues and organs of the body. This substance has many advantages. Many previous studies have shown that taurine also has a wide range of biological functions such as anti-inflammatory, analgesic, maintaining osmotic pressure balance, improving visual function, regulating blood sugar, nerve conduction, endocrine activity, regulating lipid digestion and absorption, increasing cardiac contractility, improving immunity, enhancing cell membrane antioxidant capacity, protecting myocardial cells, etc. Considering the multiple medical values of taurine and its safety, we intend to conduct a phase I-II clinical study of taurine for external use in the prevention and treatment of acute radiation skin injury for radiation skin injury, with the study period from January 25,2024 to January 25,2027. The purpose is to evaluate the safety of taurine in the prevention and treatment of acute radiation skin injury in breast cancer patients after adjuvant radiotherapy. Possible benefits: Reduce the incidence and severity of radiation skin damage.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Breast cancer patients scheduled for conventional fractionated adjuvant

• radiotherapy.

• 18 years or older

• ECOG score 0-1

• No previous history of other neoplasms.

• No previous chest radiotherapy.

• Heart, lung function, liver function and kidney function were within normal range.

• Voluntary informed consent.

Locations
Other Locations
China
Shandong Cancer Hospital
RECRUITING
Jinan
Time Frame
Start Date: 2025-05-25
Estimated Completion Date: 2027-09-25
Participants
Target number of participants: 24
Treatments
Experimental: Taurine solution ARM
Taurine solution was sprayed to the irradiated area three times a day from 1 day before the start of radiotherapy to 2 weeks after the end of radiotherapy. It is important to spray each time freshly prepared and at a fixed time each morning, noon and evening to ensure continuous contact between the drug and the skin.
Related Therapeutic Areas
Sponsors
Leads: Shandong Cancer Hospital and Institute

This content was sourced from clinicaltrials.gov