EGFR-TKIs related oral mucositis in non-small cell lung cancers
Conditions
Interventions
Experimental group:Fushan Yinhuo granules, which are be dissolved in warm water, one prescription is failed twice in the morning and evening, and will be taken continuously for 14 days
Control group:Placebo,which is similar to Fushan Yinhuo granules in shape, smell, color, taste and packaging, and the method and course of administration is consistent to experimental group.
Sponsors
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with non-small cell lung cancer whose histological or cytological diagnosis is clear. (2) EGFR sensitive mutations, including exon deletion mutations of 19, exon point mutations of 21 or other rare mutations, refer to the Clinical Practice Guidelines for Molecular Pathological Detection of Non-small Cell Lung Cancer published by the Chinese Medical Association in 2021. (3) Patients with stage IV or IIIA-IIIC tumors who cannot tolerate chemoradiotherapy. (4)Taking EGFR-TKIs, specifically referring to the latest NCCN or CSCO guidelines. Drugs are not restricted in this study, including first-generation, second-generation and even third-generation drugs. (5) In accordance with the diagnostic criteria of EGFR-TKIs related oral mucitis, TCM syndrome differentiation is Yin deficiency and Fire flourishing. (7) Function status score KPS is more than 60 points. (8) Age 18-75 years old. (9) Informed consent has been signed.
Exclusion criteria
Exclusion criteria: (1) Other diseases that may cause oral mucositis, such as Behcet's disease, malignant oral ulcers, herpetic stomatitis, oral mucositis associated with autoimmune/endocrine system diseases, etc.. (2) Oral infection is considered after routine examination including oral specialist examination, blood cell analysis and CRP. (3) Severe respiratory, circulatory, urinary, immune and blood system diseases. (4) Known allergy to test drug ingredients or iodine ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain score;Oral redness/ulceration area and number of ulcers;Quality of Life; | — |
Countries
China
Contacts
Public ContactNian Jiayun
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Outcome results
None listed