Taurine to prevent radiation-induced mouth sores and skin reactions

A Randomized Controlled Trial on Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis

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
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• 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)
• Trial ID: NCT07029178 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai ninth people's hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Heng Chen, Dr.

Conditions Radiation Induced Oral Mucositis; Radiodermatitis; double-blind; randomized controlled trial; taurine; radiodermatitis; radiation-induced oral mucositis