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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine granule | Drug | 24 grams of taurine granule + 2 Gray radiation dose each time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 subjective feeling of radiation-induced oral mucositis is evaluated via the weekly oral mucositis questionnaire during radiotherapy. | Day 1(before the first radiotherapy),8,15,22,29,36,42 (after the last radiotherapy),49±1 (follow-up),56±2 (follow-up),63±3 (follow-up),70±5 (follow-up), 126±5 (study endpoint). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate and severity of acute radiodermatitis | The severity of acute radiodermatitis is evaluated by RTOG (Radiation Therapy Oncology Group) classification. | Day 1(before the first radiotherapy),8,15,22,29,36,42 (after the last radiotherapy),49±1 (follow-up),56±2 (follow-up),63±3 (follow-up),70±5 (follow-up), 126±5 (study endpoint). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The blood immunoglobulin and CD molecule examination will be conducted during screening, on day 42 (the end of radiotherapy) and on day 70±5d. |
Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heng Chen, Dr. | Contact | +86 13761475796 | 739211733@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
| Placebo granule | Drug | 24 grams of placebo granule + 2 Gray radiation dose each time. |
|
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| Number of participants with 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, c reactive protein, procalcitonin, 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, calcium ion, magnesium ion, etc.), etc. |
| Clinical symptoms and adverse events are recorded when occured. Blood routine and blood biochemistry examination are evaluated during screening and on day 15, 29, 42 and 70±5d. |
| D014947 |
| Wounds and Injuries |