Jiedu Xiaozhen granules(JDXZ) for epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) mediated skin toxicity: A randomized controlled trial study protocol (Preprint)

BACKGROUND Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are widely used in the treatment of non-small cell lung cancer (NSCLC) 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 the patients and leading to early discontinuation of therapy. These skin reactions may even impact cancer outcomes. In clinical practice, Chinese medicine detoxification granules have shown effectiveness in relieving skin discomforts such as itching, pain, and burning caused by EGFR-TKIs therapy. A prior single-arm trial investigating the treatment of targeted drug-induced rashes demonstrated a sustained improvement in rash symptoms with an effective rate of 80.77% and was well tolerated by patients. OBJECTIVE Consequently, this randomized controlled trial (RCT) was designed to further evaluate the effectiveness and safety of Traditional Chinese Medicine (TCM) detoxification granules in the management of EGFR-TKIs mediated skin toxicity. METHODS This RCT will be conducted at Shanxi Provincial Hospital of TCM. A total of 100 patients with confirmed EGFR gene-mutated NSCLC who developed rashes after EGFR-TKIs treatment will be enrolled. Patients will be randomly assigned to either the JDXZ TCM group (Group J) or the urea ointment group (Group U). The primary outcome will be the severity of rash as assessed by NCI-CTCAE 5.0 grading. Secondary outcomes will include the WoMo score scale, numerical rating scale (NRS) scale, dermatology life quality index (DLQI) scale, EORTC QLQ C30 score, median progression-free survival (PFS), and changes in the levels of fibroblast growth factor 7 (FGF7) and hepatocyte growth factor (HGF) in blood. Adverse reactions will be recorded throughout the study. Data will be analyzed using the IBM SPSS 26.0 statistical software. RESULTS The results of this study may help develop an effective treatment for EGFR-TKIs mediated rashes. CONCLUSIONS The findings will be published in academic journals upon the completion of the trial. CLINICALTRIAL This randomized controlled trial has been registered on the Chinese Clinical Trial Registry (ChiCTR2400086657).