Clinical trial NCT06861179: The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
Official title: Basic and Clinical Studies on the Effects of the Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation Pneumonitis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory factors in blood samples of patients in the study group
timeFrame: Blood samples were collected from patients 1-3 days before the start of RT and one month after the end of RT
measure: Tumor markers in blood samples of patients in the study group
timeFrame: Blood samples were collected from patients 1-3 days before the start of RT, and one month after the end of RT
Secondary outcomes:
Other outcomes:
Locations:
city: HangZhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Wei Feng
role: STUDY_CHAIR
References:
citation: Chen H, Tian T, Miao H, Zhao YY. Traditional uses, fermentation, phytochemistry and pharmacology of Phellinus linteus: A review. Fitoterapia. 2016 Sep;113:6-26. doi: 10.1016/j.fitote.2016.06.009. Epub 2016 Jun 23.
citation: Ni Z, Li J, Qian X, Yong Y, Wu M, Wang Y, Lv W, Zhang S, Zhang Y, Shao Y, Chen A. Phellinus igniarius Polysaccharides Ameliorate Hyperglycemia by Modulating the Composition of the Gut Microbiota and Their Metabolites in Diabetic Mice. Molecules. 2023 Oct 17;28(20):7136. doi: 10.3390/molecules28207136.
citation: Zhong S, Sun YQ, Huo JX, Xu WY, Yang YN, Yang JB, Wu WJ, Liu YX, Wu CM, Li YG. The gut microbiota-aromatic hydrocarbon receptor (AhR) axis mediates the anticolitic effect of polyphenol-rich extracts from Sanghuangporus. Imeta. 2024 Mar 11;3(2):e180. doi: 10.1002/imt2.180. eCollection 2024 Apr.