Radiation Pneumonitis
Conditions
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.
Interventions
DRUGThe formulation of Compound Phellinus igniarius decoction
The formulation of Compound Phellinus igniarius decoction is manufactured by Hangzhou Qianjifang Technology Co., Ltd, the composition includes Phellinus igniarius 12g, jujube 3g, wolfberry 3g, tangerine peel 1g. The dosage regimen was as follows: 4 Packs of the formulation of Compound Phellinus igniarius decoction (Phellinus igniarius Herbal Decoction Pieces) + 1 Pack of the formulation of Compound Phellinus igniarius decoction(Excipients) per day, administered twice daily throughout the entire course of radiotherapy until its completion.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed