Clinical study on TCM treatment of EGFR-TKI
Conditions
Interventions
Experimental group:Oral detoxification and elimination granule treatment
7 days and 1 course, two consecutive treatments
Control group:Daily use of topical urea ointment to wipe the affected area
7 days 1 course, 2 continuous treatment
Sponsors
Oncology Department of Shanxi Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with NSCLC with mutations in the E GF R gene 2. Patients with skin rash after treatment using EGFR-TKI; 3. According to the NCI-CTCAE4.0 standard, the rash severity grade is in grade I~; 4. Patients are over 18 years old, without gender limitation; 5. Patient had a KPS of 60 points 6 adequate hematological, hepatic, renal and metabolic functional parameters · White blood cells> 3000 / mm · ANC 1500 / mm · Platelet 100000 / mm · Hemoglobin of> 9 g/dL · Serum creatinine 1.5 times ULN · Bilirubin 1.5 times ULN · AST / ALT 2.5 times ULN (AST / ALT 5 times ULN) · AP 5 x ULN · Magnesium, calcium and potassium within normal range (can be replaced before study start) 7. Patients who are willing to receive the study treatment and sign the informed consent form with good compliance
Exclusion criteria
Exclusion criteria: 1. Incomplete function of the viscera; 2. Clinically significant cardiovascular diseases (including myocardial infarction, unstable angina pectoris, symptomatic congestive, Heart failure, severe uncontrolled arrhythmia) for 1 year; 3. History of interstitial lung disease, such as pneumonia or pulmonary fibrosis, or evidence of interstitial lung disease on a baseline chest CT scan; 4. Rash not caused by EGFR-TKI drugs; 5. Parallel treatment with anti-tumor drugs other than this trial; 6. Recent treatment of rash-related medication; 7. Other dermatoses that may interfere with the correct grading of EGFR targeted drugs; 8. Participation in other clinical studies within 4 weeks prior to enrollment; 9. Patients with dialectical spleen and stomach deficiency and cold syndrome; 10. People who have a drug allergy to the institute; 11. Women during pregnancy or lactation, or planning to become pregnant within 6 months after the end of treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NCI-CTCAEv4.0 rash severity grade(Total Efficiency);WoMo grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin disease quality of life index;EORTC QLQ C30 Score;safety evaluation(Liver and kidney function, blood routine, use of traditional Chinese medicine and all discomfort after medication: including but not limited to nausea, vomiting, palpitations, headache, dizziness, anorexia, insomnia, diarrhea and other symptoms); | — |
Countries
China
Contacts
Public ContactLi Xiaoli
Shanxi Provincial Research Institute of Traditional Chinese Medicine
Outcome results
None listed