Radiation PneumonitisPhase 1NCT06861179
The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
A Phase 1 study testing The formulation of Compound Phellinus igniarius decoction in people with Radiation Pneumonitis, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- The formulation of Compound Phellinus igniarius decoction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 28 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basic and Clinical Studies on the Effects of 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.
Read the 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.
- Conditions
- Radiation Pneumonitis
- Being tested
- The formulation of Compound Phellinus igniarius decoction
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The formulation of Compound Phellinus igniarius decoctionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Blood samples were collected from patients 1-3 days before the start of RT, and one month after the end of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start22 Mar 2023
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wei, Zhejiang Cancer Hospital
- Investigators
- Wei Feng, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861179
- Sponsor's protocol ID
- 2022QJF0101
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27343366Ni 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.
PubMed 37894615Zhong 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.
PubMed 38882491
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic and Clinical Studies on the Effects of the Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis
- ClinicalTrials.gov ID
- NCT06861179
- Acronym / sponsor ID
- 2022QJF0101
- Conditions
- Radiation Pneumonitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis | Experimental | Drug: The formulation of Compound Phellinus igniarius decoctionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The formulation of Compound Phellinus igniarius decoctionThe 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. | Drug | the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 27343366Chen 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.
- Background: PubMed 37894615Ni 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.
- Background: PubMed 38882491Zhong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Feng study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The formulation of Compound Phellinus igniarius decoction in people with Radiation Pneumonitis, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06861179, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.