Acute Radiation Dermatitis
Conditions
Interventions
Control Group:From the first day of enrollment, patients will receive standard care only. This includes gentle cleansing of the affected skin with non-irritating cleansers, avoiding the use of soap or
Intervention Group:From the first day of enrollment, patients in the experimental group will apply Ziyuanfang Oil to the affected areas twice daily (morning and evening). A sufficient amount of Ziyuan
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed malignancy, regardless of gender. 2. Patients who develop acute radiation dermatitis (ARD) of RTOG grade I to III within 90 days after receiving 15 sessions of radiotherapy, whether or not the radiotherapy is ongoing. 3. Aged between 18 and 75 years. 4. Karnofsky Performance Status (KPS) score greater than 60, with an expected survival time of more than 3 months. 5. Able to understand and voluntarily sign the informed consent form, willing to participate in the study and comply with the study protocol. 6. Agree not to participate in other interventional studies during the study period.
Exclusion criteria
Exclusion criteria: 1. Presence of other skin diseases that may interfere with the study (e.g. eczema psoriasis) or cancer directly invading the skin (T4 TNM staging). 2. Patients who have undergone radiotherapy for more than 90 days. 3. Patients with RTOG grade IV ARD. 4. History of radiotherapy to the same site. 5. Pregnant planning to become pregnant or breastfeeding women. 6. Diabetes with poorly controlled blood glucose levels. 7. Allergic to the main ingredients of Ziyuan Oil. 8. Presence of severe systemic diseases including but not limited to: (1) severe cardiovascular diseases (e.g. myocardial infarction heart failure); (2) cerebrovascular diseases (e.g. stroke); (3) active hepatitis severe liver or kidney dysfunction. 9. Uncontrolled severe bleeding infection or chronic purulent wounds in the radiation area. 10. Uncontrolled autoimmune diseases (e.g. systemic lupus erythematosus myasthenia gravis). 11. Severe mental illness affecting study compliance (e.g. schizophrenia). 12. Low compliance due to any reason or inability to understand the research content.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RISRAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in skin damage area;Quality of life;Time for ARD relief;Radiotherapy termination rate;RTOG grading;Cumulative radiotherapy dose; | — |
Countries
China
Contacts
Public ContactYun xu
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed