The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis (NCT06861179) | Clinical Trial Compass
CompletedPhase 1
The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
China40 participantsStarted 2023-03-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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