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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis | Experimental | 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. |
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| The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis | No Intervention | he 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 control group was defined as receiving standard-dose radiotherapy without the administration of the formulation of Compound Phellinus igniarius decoction. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The formulation of Compound Phellinus igniarius decoction | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory factors in blood samples of patients in the study group | The Concentration of IL-1β、IL-6、IL-8、IL-2、IL-4、IL-5 | Blood samples were collected from patients 1-3 days before the start of RT and one month after the end of RT |
| Tumor markers in blood samples of patients in the study group | The Levels of NSE、CYFRA21-1、SCCA、CA-125、CA-199、CEA | Blood samples were collected from patients 1-3 days before the start of RT, and one month after the end of RT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Feng | Zhejiang Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27343366 | Background | 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. | |
| 37894615 | Background | 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. |
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| ID | Term |
|---|---|
| D017564 | Radiation Pneumonitis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
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| 38882491 | Background | 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. |
| D011832 |
| Radiation Injuries |
| D014947 | Wounds and Injuries |