To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer PatientsPhase 1/2NCT06847555
Phase I-II Clinical Study of Taurine for External Use in the Prevention and Treatment of Acute Radiation Skin Injury
A Phase 1/2 study testing Radiation in people with To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 25 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Has participated in other clinical trials.
- knot tissue disease
- active hepatitis
- Obvious diseases that the investigator considers should be excluded from this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Hanxi Zhao, MD, 86-531-67626996, zhx87520052@163.com
About this study
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.
Read more
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.
- Being tested
- Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate of radiation skin injury
Assessed by RTOG Grading criteria for acute radiation skin damage （0-4level）
Measured: baseline and up to 14 days post-treatment
Secondary outcomes (1)
Change in STAT criteria subjective symptom scores during treatment
Subjective symptom scores were recorded weekly with STAT table，contains burning, itching, pulling, pain and other discomfort
Measured: baseline and up to 14 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847555
- Sponsor's protocol ID
- GTEBC-2024
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Clinical Study of Taurine for External Use in the Prevention and Treatment of Acute Radiation Skin Injury
- ClinicalTrials.gov ID
- NCT06847555
- Acronym / sponsor ID
- GTEBC-2024
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taurine solution ARM | Experimental | Radiation: RadiationTaurine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Breast cancer patients scheduled for conventional fractionated adjuvant
- radiotherapy.
- 18 years or older
- ECOG score 0-1
- No previous history of other neoplasms.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationTumor 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. | Radiation | Taurine solution ARM |
Primary outcome
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）
1 secondary outcome
Change in STAT criteria subjective symptom scores during treatment
Time frame: baseline and up to 14 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation in people with To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate of radiation skin injury (time frame: baseline and up to 14 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.