A single-arm clinical study of honeysuckle oral liquid in the treatment of non-small cell lung cancer EGFR-TKIs-associated oral mucositis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080892

Enrollment

Unknown

Registered

2024-02-17

Start date

2024-02-18

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

EGFR-TKIs-related oral mucositis

Interventions

Experimental group:Honeysuckle oral liquid (Zhenao Honeysuckle Pharmaceutical Co., Ltd.: approval number: Guoyao Zhunzi Z20113081, China invention patent: patent number ZL201510283985.8), 20ml/piece,

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with non-small cell lung cancer with clear histological or cytological diagnosis; (2) EGFR-sensitive mutations: including exon 19 deletion mutations, exon 21 point mutations or other rare mutations, please 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) Those who are taking EGFR-TKIs drugs, refer to the latest NCCN or CSCO guidelines for details, and there are no restrictions in this study, including first-generation, second-generation, and even third-generation drugs; (4) Meet the diagnostic criteria for EGFR-TKIs-related oral mucositis, and the TCM syndrome differentiation is a real heat syndrome; (5) Oral mucositis is graded as grade 1-3 (WHO standard); (6) Functional status score KPS greater than 60 points; (7) Age 18-75 years old; (8) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Exclude other diseases that may cause oral mucositis, such as: Behcet's disease, malignant oral ulcer, herpetic stomatitis, oral mucositis associated with autoimmune/endocrine system diseases, etc.; (2) Oral infection should be considered after routine examinations such as dental examination, blood cell analysis and CRP; (3) Severe respiratory, circulatory, urinary, immunological and hematologic diseases; (4) Those who are known to be allergic to the test drug ingredients; (5) Patients who have received chemoradiotherapy and immunotherapy within 2 weeks.

Design outcomes

Primary

Measure	Time frame
The total response rate of treatment;	—

Secondary

Measure	Time frame
Oral mucositis graded;NRS pain score;The area of redness/ulceration in the mouth and the number of ulcers;Quality of life scores;	—

Countries

China

Contacts

Public ContactXiaoMin Wang

Beijing Hospital of Traditional Chinese Medicine

wangxiaomin_bhtcm@126.com+86 130 5127 2736

Outcome results

None listed

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