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

NCT06847555 | Recruiting Phase 1

• 1 other identifier: GTEBC-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Objective remission rate of radiation skin injury

  Assessed by RTOG Grading criteria for acute radiation skin damage （0-4level）

  baseline and up to 14 days post-treatment

Secondary Outcomes (1)

• Change in STAT criteria subjective symptom scores during treatment

  baseline and up to 14 days post-treatment

Study Arms (1)

Taurine solution ARM

EXPERIMENTAL

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.

Radiation: Radiation

Interventions

Radiation RADIATION

Tumor radiotherapy is a method of treating malignant tumors by using radioactive rays such as alpha, beta, gamma rays produced by radioactive isotopes and x-rays, electron rays, proton beams and other particle beams produced by various x-ray therapy machines or accelerators.

Taurine solution ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients scheduled for conventional fractionated adjuvant
• radiotherapy.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: February 26, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): September 25, 2027
• Study Completion (Estimated): September 25, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

CN (1)