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New treatment option for Radiation Induced Oral Mucositis
Official title Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis
ClinicalTrials.gov ID: NCT07029178
What this study is testing
What is Taurine granule?
Taurine granule is an investigational medicine, being studied as a potential treatment for radiation induced oral mucositis.
Also referred to as Radiotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, double-blind, randomized controlled study. The patients were divided into control group and experimental group, 80 cases each.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- 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...
- 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...
You likely can't join 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...
- Arterial/venous thrombosis that occurred within 6 months prior to the screening, such as cerebrovascular accidents, deep vein thrombosis and...
- 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)...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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.
- Patients who, in addition to radiotherapy, requires chemotherapy or immunotherapy simultaneously.
- Mental illness, alcohol abuser, drug user or drug abuser.
- Pregnant or lactating women; Women who plans to become pregnant within half a year after treatment.
- Poor compliance or other circumstances assessed by the researcher as unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.