Jiedu Xiaozhen Granules for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor-Mediated Skin Toxicity: Protocol for a Randomized Controlled Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 94 participants or records.
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