Radiation ToxicityFIRILINCT05616507
Oligo-Fucoidan Decrease Lung Radiation Damage
A study testing fucoidan in people with Radiation Toxicity, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Fucoidan is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Radiation Toxicity
- What is being tested?
- fucoidan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Mar 2022to 30 Dec 2025
- Phase
- Interventional
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages Eligible for Study: 20-90 years old
- Men and women undergoing radiation therapy for lung cancer，no matter the radiation therapy is for curing or for palliating.
- Karnofsky performance status，KPS > 70
- Absolute Neutrophils > 1000/mm^3
- Platelets > 75,000/mm^3
- Hematocrit > 25%.
- Liver and kidney function tests will be within normal range
- Baseline blood pressure will be systolic > 110 mmHg sitting
Who cannot join
- Patients who get lung cancer but no need or without the willingness of radiation therapy
- Patients who are taking antiHTN drugs
- Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
- Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
- Patients who are judged to be ineligible for study entry by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Szu-Yuan Wu
Taipei, Please Select, 116
Szu-Yuan Wu, 0910603955, szuyuanwu5399@gmail.com
About this study
Official title: A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
Fucoidan is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
Read the detailed description
This project will test the effect of Fucoidan to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in laboratory animals show that with Fucoidan, investigators can significantly reduce the severity of lung fibrosis and heart toxicity.1,2 Fucoidan is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
- Conditions
- Radiation Toxicity
- Being tested
- fucoidan
- Keywords
- radiation pneumonitis, fucoidan, radiation induced cardiac toxicity
- Medical subject headings
- Radiation Injuries, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fucoidanDietary supplement
It is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | It is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. Receives: Dietary Supplement: fucoidan |
| Arm B | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Radiation Pneumonitis
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)
Measured: 6 months
Secondary outcomes (2)
Number of Participants With Radiation Pneumonitis
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)
Measured: one year
Number of Participants With Radiation Pneumonitis
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)(Grade 0-5)
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start30 Mar 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asia University
- Responsible party
- Sponsor
- Investigators
- Szu-Yuan Wu, Study director, Asia University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616507
- Sponsor's protocol ID
- IRB109-196-A
- Acronym
- FIRILI
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study completed
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
- ClinicalTrials.gov ID
- NCT05616507
- Acronym / sponsor ID
- FIRILI / IRB109-196-A
- Conditions
- Radiation Toxicity
- Keywords
- radiation pneumonitis, fucoidan, radiation induced cardiac toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Collaborators
- Asia University
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Nov 2022 (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.
Fucoidan is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
Detailed description
This project will test the effect of Fucoidan to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in laboratory animals show that with Fucoidan, investigators can significantly reduce the severity of lung fibrosis and heart toxicity.1,2 Fucoidan is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Dietary Supplement: fucoidanIt is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. |
| Arm B | No intervention | –observation |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages Eligible for Study: 20-90 years old
- Men and women undergoing radiation therapy for lung cancer，no matter the radiation therapy is for curing or for palliating.
- Karnofsky performance status，KPS > 70
- Absolute Neutrophils > 1000/mm^3
- Platelets > 75,000/mm^3
Key exclusion criteria (5 listed)
- Patients who get lung cancer but no need or without the willingness of radiation therapy
- Patients who are taking antiHTN drugs
- Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
- Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
- Patients who are judged to be ineligible for study entry by the investigator or subinvestigator
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 |
|---|---|---|
| fucoidanIt is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. | Dietary supplement | Arm A |
Primary outcome
Number of Participants With Radiation Pneumonitis
Time frame: 6 months
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)
2 secondary outcomes
Number of Participants With Radiation Pneumonitis
Time frame: one year
Number of Participants With Radiation Pneumonitis
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Yes. study completed
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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.
Szu-Yuan Wu study director
Asia University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fucoidan in people with Radiation Toxicity, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Szu-Yuan Wu (+886910603955, szuyuanwu5399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Radiation Pneumonitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2022.