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

February 24, 2025 updated by: Han Xi Zhao, Shandong Cancer Hospital and Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate of radiation skin injury
Time Frame: baseline and up to 14 days post-treatment
Assessed by RTOG Grading criteria for acute radiation skin damage （0-4level）
baseline and up to 14 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in STAT criteria subjective symptom scores during treatment
Time Frame: baseline and up to 14 days post-treatment
Subjective symptom scores were recorded weekly with STAT table，contains burning, itching, pulling, pain and other discomfort
baseline and up to 14 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 25, 2025

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

September 25, 2027

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTEBC-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Clinical Trials on Radiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe