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NCT06847555
Phase I-II Clinical Study of Taurine for External Use in the Prevention and Treatment of Acute Radiation Skin Injury
Phase 1, PHASE2 trial testing Radiation in To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients in 24 participants. Currently enrolling.
25 September 2027
Quick facts
| Lead sponsor | Shandong Cancer Hospital and Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 24 |
| Start date | 25 May 2025 |
| Primary completion | 25 September 2027 |
| Estimated completion | 25 September 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radiation
Conditions studied
- To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients — all drugs for To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients →
Sponsor
Shandong Cancer Hospital and Institute
Who can join
18 and older, female only, with To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06847555 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shandong Cancer Hospital and Institute
- Last refreshed: 26 February 2025
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