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NCT Number: NCT06861179

The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Inflammatory factors in blood samples of patients in the study group

    Time frame: 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

  2. Tumor markers in blood samples of patients in the study group

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Basic and Clinical Studies on the Effects of the Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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