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

NCT07029178 | Recruiting Phase 2 DMC

• 1 other identifier: JYKQ-2025-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Induced Oral Mucositis; Radiodermatitis

Keywords

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

Outcome Measures

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.

  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 (2)

• Incidence rate and severity of acute radiodermatitis

  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).

• Safety physiological parameters

  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 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.

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Taurine group

EXPERIMENTAL

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

Placebo granule DRUG

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

Also known as: Radiotherapy

Control group

Taurine granule DRUG

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

Also known as: Radiotherapy

Taurine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18 to 80, with no gender restrictions.
• Patients that require radiotherapy after surgery for oral/oropharyngeal cancer. After evaluation by the radiation oncologist, radiotherapy at 30 sessions /60Gy is planned.
• The expected survival period is more than 6 months.
• 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.

You may not qualify if:

• Uncontrollable local or systemic infections of the oral cavity and head and neck.
• Active or history of autoimmune diseases; Diseases requiring systemic steroid hormones or immunosuppressive medications.
• 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.
• Arterial/venous thrombosis that occurred within 6 months prior to the screening, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc.
• Interstitial pneumonia or active pneumonia with clinical significance, or other respiratory diseases that seriously affect lung function.
• 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.
• Severe endocrine or hematopoietic system diseases (such as diabetes, leukemia, etc.), gastrointestinal obstruction, active bleeding, gastric perforation and other conditions.
• Combined with malignant tumors of other organs.
• Intractable or refractory epilepsy, with a large amount of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by medicines.
• 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.
• History of allogeneic bone marrow transplantation or solid organ transplantation.
• Have received cell therapy products that have undergone genetic modification or editing in the past.
• Have previously used medicines that can cause medication-related osteonecrosis of the jaw.
• Have taken drugs containing taurine within one month before randomization in this study.
• Allergic to taurine.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Heng Chen, Dr.

CONTACT

+86 13761475796; 739211733@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 by CRC. After the patient take the medication, the CRC takes the patient to the treatment room for radiotherapy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section head

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 19, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2025-11

Locations

CN (1)