The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

NCT06861179 | Completed Phase 1 DMC

• 1 other identifier: 2022QJF0101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Pneumonitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: The formulation of Compound Phellinus igniarius decoction

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.

Interventions

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.

the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (3)

• 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.

  PMID: 27343366 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.

  PMID: 37894615 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.

  PMID: 38882491 BACKGROUND

MeSH Terms

Conditions

Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Officials

• Wei Feng

  Zhejiang Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: March 22, 2023
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)