The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

Phase 1

Completed

• Conditions: Radiation Pneumonitis
• Interventions: Drug: The formulation of Compound Phellinus igniarius decoction

• Registration Number: NCT06861179
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

The objectives of this clinical trial were to determine the radioprotective effects and underlying biological mechanisms of Phellinus igniarius and its active components during radiotherapy in patients with thoracic malignant tumors.

The study group was given the formulation of Compound Phellinus igniarius decoction daily during radiotherapy, 150ml bid until the end of radiotherapy; The control group only received standard dose radiotherapy without the formulation of Compound Phellinus igniarius decoction intervention.

The baseline differences between the two groups were compared, including gender, smoking history, body mass index (BMI), pathological classification, median age of onset, inflammatory factors, tumor markers, TNM stage, KPS score, fatigue score, incidence and grade of radiation pneumonitis, incidence of other radiotherapy-related adverse reactions, and average radiation dose.

Detailed Description

Investigators measured the levels of inflammatory factors and tumor markers in blood samples of patients in the two income groups, and administered questionnaires on the degree of fatigue and general status of patients. Metabolite changes and gut microbiota homeostasis in patient fecal samples were then detected by untargeted metabolomics and metagenomics.

Study Timeline

• Study Start: 2023-03-22
• Primary Completion: 2024-12-28
• Study Completion: 2024-12-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-02
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥18 years, ECOG score≤2, possess adequate communication and comprehension abilities, and have an anticipated survival time exceeding 6 months
• Confirmed diagnosis of lung malignancy through imaging and pathological examination
• Indications for thoracic radiotherapy, DT:50-60Gy/20-30F
• Normal function of vital organs, including the heart, liver, kidneys, and gastrointestinal system

Exclusion Criteria

• Patients with pre-existing pulmonary conditions, including idiopathic pulmonary fibrosis
• Individuals with systemic immune disorders
• Those with concurrent major infections
• Patients diagnosed with hematological disorders. All participants provided written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis	The formulation of Compound Phellinus igniarius decoction	The patients were randomly allocated into two groups, each comprising 20 patients. All patients received with DT: 50-60 Gy/20-30F thoracic radiotherapy, all with 6mv linear accelerator irradiation. The study group was defined as receiving the formulation of Compound Phellinus igniarius decoction, 150ml bid was administered continuously until the end of radiotherapy.

Primary Outcome Measures

Name	Time	Method
Inflammatory factors in blood samples of patients in the study group	Blood samples were collected from patients 1-3 days before the start of RT and one month after the end of RT	The Concentration of IL-1β、IL-6、IL-8、IL-2、IL-4、IL-5
Tumor markers in blood samples of patients in the study group	Blood samples were collected from patients 1-3 days before the start of RT, and one month after the end of RT	The Levels of NSE、CYFRA21-1、SCCA、CA-125、CA-199、CEA

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 HangZhou, Zhejiang, China