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Clinical study on the treatment of EGFR-TKIs-related rash in non-small cell lung cancer by cooling blood and detoxifying toxin method

Clinical study on the treatment of EGFR-TKIs-related rash in non-small cell lung cancer by cooling blood and detoxifying toxin method

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001487
Enrollment
Unknown
Registered
2025-07-26
Start date
2025-05-13
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LUNG CANCER

Interventions

control group:Routine Western medical management such as tetracycline minocycline or roxithromycin may be applied topically 1–3 times daily without restriction. The placebo consists of 5 % of the orig
experimental group:blood-cooling and detoxification formula+Routine Western medical management such as tetracycline minocycline or roxithromycin may be applied topically 1–3 times daily without restri

Sponsors

Beijing Shijitan HospitalCapital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients undergoing EGFR-TKIs targeted therapy for IIIB and stage IV NSCLC (2) Patients who meet the diagnostic criteria for acne-like rash associated with EGFR-TKIs therapy with rash grade =1 (3) Patients with blood-heat and toxin-containing symptoms (4) Aged 18-80 years (5) Expected survival = 3 months KPS functional status score = 70 points (6) Subjects without major organ dysfunction such as severe heart liver and kidney impairment or serious primary diseases (7) Good compliance and signing of informed consent before enrollment

Exclusion criteria

Exclusion criteria: (1) Subjects with known or suspected hypersensitivity to known components of the study drug (2) Subjects with intestinal obstruction that cannot be treated with oral medication requiring intravenous high-energy nutrition or suffering from severe malabsorption or other diseases that affect absorption in the gastrointestinal tract. (3) Those who are unable to understand read and fill in the patient self-assessment scale due to their knowledge or intelligence. (4) Pregnant and lactating women (5) Combination of other skin diseases such as eczema psoriasis atopic dermatitis etc. The researcher decides that they are not suitable to participate in this study

Design outcomes

Primary

MeasureTime frame
Overall Effective Rate of Rash;

Secondary

MeasureTime frame
Cytokine Assay;Dermatology Life Quality Index (DLQI) and Karnofsky Performance Status (KPS);Immune Function Testing;Traditional Chinese Medicine Syndrome Score;

Countries

China

Contacts

Public ContactJiang Min

Beijing Shijitan HospitalCapital Medical University

jiangm1965@sina.com15253063568

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026