Jiedu Xiaozhen Granules for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor-Mediated Skin Toxicity: Protocol for a Randomized Controlled Trial.

[BACKGROUND] Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are widely used in the treatment of non-small cell lung cancer due to their precision, efficiency, and ease of use. However, skin rashes induced by EGFR-TKIs are the most common and earliest form of skin toxicity, often affecting the quality of life and treatment compliance of patients and leading to early discontinuation of therapy. These skin reactions may even impact cancer outcomes. In clinical practice, traditional Chinese medicine detoxification granules have shown effectiveness in relieving skin discomforts such as itching, pain, and burning caused by EGFR-TKI therapy. A prior single-arm trial investigating the treatment of targeted drug-induced rashes demonstrated a sustained improvement in rash symptoms with an effectiveness rate of 80.77% and was well tolerated by patients.

[OBJECTIVE] As an exploratory clinical study, this randomized controlled trial will preliminarily evaluate the potential efficacy and safety of jiedu xiaozhen (JDXZ) granules in managing EGFR-TKI-related skin toxicities.

[METHODS] This randomized controlled trial will be conducted at Shanxi Provincial Hospital of Traditional Chinese Medicine. A total of 94 patients with confirmed epidermal growth factor receptor gene-mutated non-small cell lung cancer who developed rashes after EGFR-TKI treatment will be enrolled. Patients will be randomly assigned to either a JDXZ traditional Chinese medicine group (group J) or a urea ointment group (group U). The primary outcome will be the severity of the rash as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events grading. Secondary outcomes will include the WoMo (Wollenberg and Moosmann) score, numerical rating scale, Dermatology Life Quality Index scale, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 score, median progression-free survival, and changes in the levels of fibroblast growth factor 7 and hepatocyte growth factor in the blood. Adverse reactions will be recorded throughout the study. Data will be analyzed using SPSS.

[RESULTS] The clinical trial registration was completed in October 2024. This study is currently underway. As of December 1, 2025, a total of 81 eligible participants had been enrolled, all of whom were assigned to groups following the randomization principle. Among them, 42 participants were allocated to the JDXZ group (with an additional 2 participants pending enrollment), and 39 to the control group. Based on the current progress, the estimated trial completion date has been extended to January 31, 2026.

[CONCLUSIONS] The results of this study may help develop an effective treatment for EGFR-TKI-mediated rashes. The findings will be published in academic journals upon the completion of the trial.