CClinicalTrials.gg
RecruitingNCT07029178Updated Jul 23, 2026

Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis

A Phase 2 interventional study of Taurine granule and Placebo granule in Radiation Induced Oral Mucositis and Radiodermatitis, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a single-center, double-blind, randomized controlled study. The patients were divided into control group and experimental group, 80 cases each. From the first day of radiotherapy to the end of radiotherapy, the experimental group was treated with 24 grams of taurine granule (containing 4.8 grams of taurine) before each day's radiotherapy. The control group was treated with the same amount of placebo.

Read the detailed description

Implementation of double-blind:

Doctors, patients and clinical research coordinator (CRC) are blind. The medicine will be encoded before the beginning of the trial, and will be administered before each radiotherapy session. After the patient take the medication, the CRC takes the patient to the treatment room for radiotherapy.

02

Conditions studied

  • Radiation Induced Oral Mucositis
  • Radiodermatitis

Browse trials for

Keywords

  • double-blind
  • randomized controlled trial
  • taurine
  • radiodermatitis
  • radiation-induced oral mucositis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Placebo comparator
    Control group

    From the first day of radiotherapy to the end of radiotherapy, the control group was treated with 24 grams of placebo before each day's radiotherapy.

    Drug: Placebo granule

  • Experimental
    Taurine group

    From the first day of radiotherapy to the end of radiotherapy, the experimental group was treated with 24 grams of taurine granule (containing 4.8 grams of taurine) before each day's radiotherapy.

    Drug: Taurine granule

Interventions

  • DrugTaurine granule

    24 grams of taurine granule + 2 Gray radiation dose each time.

    Also known as: Radiotherapy

  • DrugPlacebo granule

    24 grams of placebo granule + 2 Gray radiation dose each time.

    Also known as: Radiotherapy

05

What researchers measure

Primary outcomes

  1. Incidence rate and severity of acute radiation-induced oral mucositis

    The severity of acute radiation-induced oral mucositis is evaluated by RTOG (Radiation Therapy Oncology Group) classification.

    Time frame: The first day, the second, third, fourth, fifth, sixth week during radiotherapy; the 7±1 day, the 14±2 day, the 21±3 day, the 28±5 day after the last day of radiotherapy (follow-up); 3 month±5 days after the last day of radiotherapy (study endpoint).

Secondary outcomes

  1. Incidence rate and severity of acute radiodermatitis

    The severity of acute radiodermatitis is evaluated by RTOG (Radiation Therapy Oncology Group) classification.

    Time frame: The first day, the second, third, fourth, fifth, sixth week during radiotherapy; the 7±1 day, the 14±2 day, the 21±3 day, the 28±5 day after the last day of radiotherapy (follow-up); 3 month±5 days after the last day of radiotherapy (study endpoint).

  2. Safety physiological parameters

    The safety of placebo granule and taurine granule is evaluated by clinical symptoms, adverse events (assessed by CTCAE v5.0), blood routine examination (including red blood cells, hemoglobin, blood platelet, white blood cell, basophilic granulocyte, Eosinophils, lymphocyte, mononuclear leucocyte, neutrophil, etc.), blood biochemistry examination (including alanine transaminase, glutamic-pyruvic transaminase, alkaline phosphatase, total protein, albumin, total bilirubin, direct bilirubin, blood urea nitrogen, creatinine, potassium ion, sodion, chloridion, etc.).

    Time frame: Clinical symptoms and adverse events are recorded when occured. Blood routine and blood biochemistry examination are evaluated during screening, after 2/4/6 weeks of radiotherapy and 4 weeks after the last day of radiotherapy.

Other outcomes

  1. Immunological parameters of peripheral blood

    The immunomodulatory effects of placebo granule and taurine granule is evaluated by blood immunoglobulin examination (IgA、IgG、IgE、IgM) and blood CD molecule (CD3、CD4、CD8、CD16、CD19、CD56) examination.

    Time frame: The blood immunoglobulin and CD molecule examination will be conducted during screening, during the last week of radiotherapy and 4 weeks after the last day of radiotherapy.

06

Study locations

1 of 1 sites recruiting
  • Shanghai ninth people's hospital
    Shanghai, Shanghai Municipality 200011, China
    Recruiting
07

Registry details

Key details

Study ID
NCT07029178
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible party
Yue He, MD (Section head, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University) — Principal investigator
First posted
Jun 19, 2025
Start date
Nov 24, 2025
Primary completion
Nov 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 23, 2026

Study contacts

Heng Chen, Dr.
Contact
739211733@qq.com
+86 13761475796

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion