Taurine to prevent radiation-induced mouth sores and skin reactions
Official title: A Randomized Controlled Trial on Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis
Run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · NCT07029178 · Data updated 2026-11-12
This trial will test whether taking a daily taurine granule before each radiotherapy session reduces radiation-induced oral mucositis and radiodermatitis in adults receiving postoperative radiotherapy for oral/oropharyngeal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07029178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 scheduled for postoperative radiotherapy to the oral/oropharyngeal region (30 sessions/60 Gy), with expected survival >6 months and no recent chemotherapy, immunotherapy, or prior head and neck radiotherapy.
✕Probably not a fit
Patients with uncontrolled local or systemic oral/head and neck infections, active or past autoimmune disease requiring systemic steroids or immunosuppressants, recent significant bleeding, or recent chemotherapy/immunotherapy are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, double-blind, randomized Phase 2 trial in Shanghai enrolls 160 patients randomized 1:1 to receive either taurine granules or placebo before each radiotherapy session. Participants are adults (18–80) planned for postoperative head and neck radiotherapy (30 sessions, 60 Gy) with expected survival >6 months and no prior head/neck radiotherapy. The experimental arm receives 24 grams of granule containing 4.8 grams of taurine before each daily fraction; the control arm receives an identical placebo, and doctors, patients, and clinical research coordinators are blinded. Outcomes include the occurrence and severity of oral mucositis and radiodermatitis during and after radiotherapy to see if taurine reduces treatment-related toxicity.
Why it matters
Potential benefit: If successful, taurine could reduce the severity and frequency of radiation-induced mouth sores and skin reactions, improving patient comfort and reducing treatment interruptions.
How similar studies have gone: Preclinical work and small clinical reports suggest taurine has antioxidant and mucosal-protective effects, but robust randomized data specifically for radiation-induced oral mucositis and radiodermatitis are limited, so this approach remains relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients voluntarily joined the study, were informed of the purpose and process of the study, signed the informed consent form, and were willing and able to abide by the study protocol. 2. Aged 18 to 80, with no gender restrictions. 3. Patients that require radiotherapy after surgery for oral/oropharyngeal cancer. After evaluation by the radiation oncologist, radiotherapy at 30 sessions /60Gy is planned. 4. The expected survival period is more than 6 months. 5. No radiotherapy for the head and neck has been performed in the past, and no other medications that affect the results of this trial have been used. No chemotherapy or immunotherapy was performed within one month before the beginning of the trial. Exclusion criteria: 1. Uncontrollable local or systemic infections of the oral cavity and head and neck. 2. Active or history of autoimmune diseases; Diseases requiring systemic steroid hormones or immunosuppressive medications. 3. Bleeding occurred within 3 months before enrollment, including but not limited to: gastrointestinal bleeding caused by gastric fundus or esophageal varices, increased risk of bleeding caused by portal hypertension, active gastrointestinal bleeding, etc. Or there is a risk of major bleeding as assessed by the researcher. 4. Arterial/venous thrombosis that occurred within 6 months prior to the screening, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc. 5. Interstitial pneumonia or active pneumonia with clinical significance, or other respiratory diseases that seriously affect lung function. 6. History of cardiovascular diseases, including but not limited to: (1) Congestive heart failure (NYHA grade \> 2); (2) Unstable angina pectoris; (3) Myocardial infarction occurred in the past three months; (4) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment or intervention. 7. Severe endocrine or hematopoietic system diseases (such as diabetes, leukemia, etc.), gastrointestinal obstruction, active bleeding, gastric perforation and other conditions. 8. Combined with malignant tumors of other organs. 9. Intractable or refractory epilepsy, with a large amount of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by medicines. 10. History of HIV, syphilis, active hepatitis, active pulmonary tuberculosis, active EBV and/or CMV infection within one year before screening, or those with a history of active pulmonary tuberculosis infection for more than one year without regular treatment; active hepatitis B or C. Patients with positive HBsAg or HBcAb can participate in this study if the HBV DNA test is below the lower limit of the normal value detected by the research center; patients with positive HCV antibody can participate in this study if the HCV RNA test is below the lower limit of the normal value detected by the research center. 11. History of allogeneic bone marrow transplantation or solid organ transplantation. 12. Have received cell therapy products that have undergone genetic modification or editing in the past. 13. Have previously used medicines that can cause medication-related osteonecrosis of the jaw. 14. Have taken drugs containing taurine within one month before randomization in this study. 15. Allergic to taurine. 16. Patients who, in addition to radiotherapy, requires chemotherapy or immunotherapy simultaneously. 17. Mental illness, alcohol abuser, drug user or drug abuser. 18. Pregnant or lactating women; Women who plans to become pregnant within half a year after treatment. 19. Poor compliance or other circumstances assessed by the researcher as unsuitable for participation in this clinical study.
Where it's running
-
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Heng Chen, Dr.
- Email: 739211733@qq.com
- Phone: +86 13761475796
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Topical Boswellia 2% Cream to Prevent Radiation Dermatitis in Head and Neck Cancer
A topical 2% Boswellia serrata cream is tested to see if it can prevent skin irritation from radiation in people with head and neck cancer.
-
Houyanqing oral liquid to prevent and treat radiation mouth sores in nasopharyngeal cancer
This phase 3 trial will test whether adding Houyanqing oral liquid to standard care can prevent or lessen radiation-caused mouth sores in adults receiving radiotherapy for nasopharyngeal cancer.
-
TCM oral liquid plus herbal mouthwash for radiation‑caused mouth sores in head and neck cancer
This study will test whether taking a Qingying oral liquid and using a modified Da Huang‑Huang Lian Xiexin mouthwash can reduce how often, how long, and how severe radiation‑induced mouth sores are in adults receiving radiotherapy for head and neck cancer.
-
Rice bran for radiation-related mouth sores in head and neck cancer
This trial will try rice bran supplements during radiation to see if adults with head and neck cancer have fewer or less severe mouth sores.
-
Using hydroxychloroquine to prevent and treat oral mucositis from radiation therapy
This study is testing if hydroxychloroquine can help prevent and treat mouth sores in people getting radiation therapy for head and neck cancer.
-
Observational study on a new method for managing radiation-induced mouth sores in cancer patients
This study is testing a new method to see if it can help predict and manage mouth sores in cancer patients receiving radiation treatment for nasopharyngeal carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.