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

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a substance called taurine to help prevent and treat skin damage caused by radiation therapy in women with breast cancer. Radiation therapy can often lead to skin injuries, such as redness, peeling, or even severe ulcers, which can be painful and affect a patient's quality of life. The researchers want to see if applying taurine to the skin can reduce these side effects and make the treatment process easier for patients.

To participate in this study, women must be at least 18 years old, scheduled to receive radiation therapy for breast cancer, and generally healthy, with normal heart, lung, liver, and kidney function. Participants will be monitored for their safety throughout the trial, which runs from January 2024 to January 2027. The goal is to determine if taurine can effectively reduce the severity of skin damage during radiation therapy, potentially improving the overall experience for breast cancer patients undergoing treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Pregnant or lactating women, women in childbearing years who do not use effective contraception；
• • Patients with mental disease or nervous system disease, unable to clearly describe treatment response (such as cerebrovascular accident sequela);
• • Those who have serious heart, liver, kidney and other organ diseases or diabetes and are not expected to complete the treatment plan;
• • serious, uncontrolled diseases and infections;
• • Pregnant or lactating patients.
• • Allergic to taurine and any of its components.
• • Has participated in other clinical trials.
• • knot tissue disease
• • active hepatitis
• • Obvious diseases that the investigator considers should be excluded from this study