acute radiation-induced oral mucositis and radiodermatitis.
Conditions
Interventions
Taurine:Taurine granule
Control:Placebo granule
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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, bilateral 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, immunotherapy or targeted therapy was performed within one month before the beginning of the trial.
Exclusion criteria
Exclusion criteria: 1.Uncontrollable local or systemic infections of the oral cavity and head and neck; 2.Active autoimmune diseases, history of autoimmune diseases, or diseases requiring systemic steroid hormones or immunosuppressive drug treatment; 3.Bleeding that occurred within 3 months before screening, 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 events that occurred within 6 months before the screening, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc; 5.Interstitial pneumonia or active pneumonia with clinical significance at the time of screening, or other respiratory diseases that seriously affect lung function; 6.History of cardiovascular diseases of significant clinical significance, 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.Serious 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.Refractory or intractable epilepsy, as well as a large amount of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by medications; 10.Infectious diseases within one year before screening, such as HIV, syphilis, active hepatitis, active pulmonary tuberculosis, active EBV and/or CMV infection, or have a history of active pulmonary tuberculosis infection for more than one year but have not received formal treatment; Active hepatitis B or hepatitis C Subjects positive for HBsAg or HBcAb can participate in this study if the DNA test of HBV is less than the lower limit of the normal value detected by the research center where they are located. Subjects with positive HCV antibodies can participate in this study if the RNA detection of HCV is less than the lower limit of the normal value detected by the research center where they are locate; 11.Received allogeneic bone marrow transplantation or solid organ transplantation in the past; 12.Usage of cell therapy products that have undergone genetic modification or editing in the past; 13.Have used medications that could cause medication-related osteonecrosis of the jaw; 14.Medications containing taurine were taken within one month before randomization of this study; 15.Allergic to taurine; 16.Patients who, in addition to radiotherapy, requires chemotherapy, immunotherapy and targeted therapy simultaneously; 17.Mental illness, alcohol abuse, drug use or drug abuse; 18.Pregnant or lactating women or women who are pregnant, breastfeeding or planning to become pregnant within half a year after treatment; 19.Poor compliance or other circumstances evaluated by the researcher as unsuitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of radiation-induced oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of radiodermatitis;Safety;Immunity; | — |
Countries
China
Contacts
Public ContactYue He
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed