Efficacy and safety of topical Xiaozhenzhiyang in the treatment of epidermal growth factor receptor (EGFR) inhibitor-associated rash: a multiple center, randomized, double blinding, placebo-controlled tri

Phase 1

Not yet recruiting

• Conditions: on-small cell lung cancer

• Registration Number: ITMCTR2000002966
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Sign the informed consent, male and female aged at least 18 years old;
2. Patients with non-small cell lung cancer (NSCLC) are diagnosed by histology or cytology, EGFR gene mutation-positive;
3. The facial rash develops after taking EGFR-TKIs drugs;
4. Patient aware of what condition with and understand the content of written informed consent form;
5. Life expectancy is greater than or equal to 3 months;
6. willing to abide by the agreement, use therapeutic agents according to doctor's advice, and accept regular follow-up with good compliance;
7. Complete the questionnaire by yourself or with assistance;
8. ECOG PS score 0-3 points;
9. All screening laboratory tests are performed according to the program requirements and need to be carried out within 14 days before the first dose; The values of the laboratory tests performed for screening must meet the following criteria:
1) Blood routine examination: (no blood transfusion within 14 days before screening, no use of G-CSF, no use of drugs to correct); hemoglobin (HB) >=90 g/L; absolute value of neutrophil count (ANC) >=1.5 x 10^9/L; platelet count (PLT) >=100x10^9/L; white blood cell count (WBC) >=4.0x10^9/L and <=15x10^9/L;
2) Biochemical examination: (no blood transfusion or albumin within 14 days before screening): AST and ALT <=1.5 times upper limit of normal (ULN) (if there is tumor liver metastasis, <=5 times ULN); ALP <=2.5 times ULN (if there is tumor bone metastasis, <=5 times ULN); TBiL<=1.5 times ULN; ALB>=30g/L; Cr <=1.5 times ULN, while creatinine clearance (CrCL) >=60 mL/min (Cockcroft-Gault formula); APTT <=1.5 times ULN, while INR or PT <=1.5 times ULN (no anticoagulant therapy).
10. Patients who are unwilling to receive randomization can enter the observational cohort for treatment other than the randomized controlled protocol.

Exclusion Criteria

1. Skin rashes caused by other reasons;
2. Use of drugs that may affect the results of the trial within 14 days (within the 14 days of day 0 (baseline), concurrent use of topical antibiotics, topical steroids, and other local treatments; use of any systemic antibiotic therapy within seven days before day 0);
3. Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmia or mental illness;
4. Subjects with mental illness, alcoholism, drug abuse or substance abuse;
5. Based on the investigator's judgment, exclude subjects with any disease that may confuse the results of the study, interfere with the subject's participation in the research process, or are not in the best interest of the subject to participate in the research, or have treatment or laboratory abnormalities Subjects with past and present medical history.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified