Back to resultsOligo-Fucoidan Decrease Lung Radiation Damage (FIRILI)
Primary Purpose
Radiation Toxicity
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
fucoidan
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Toxicity focused on measuring radiation pneumonitis, fucoidan, radiation induced cardiac toxicity
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Szu-Yuan WuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A
Arm B
Arm Description
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.
observation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Full Information
NCT ID
NCT05616507
First Posted
April 7, 2022
Last Updated
November 13, 2022
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Asia University
1. Study Identification
Unique Protocol Identification Number
NCT05616507
Brief Title
Oligo-Fucoidan Decrease Lung Radiation Damage
Acronym
FIRILI
Official Title
A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Asia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Toxicity
Keywords
radiation pneumonitis, fucoidan, radiation induced cardiac toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
observation
Intervention Type
Dietary Supplement
Intervention Name(s)
fucoidan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Radiation Pneumonitis
Description
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Radiation Pneumonitis
Description
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)
Time Frame
one year
Title
Number of Participants With Radiation Pneumonitis
Description
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)(Grade 0-5)
Time Frame
two year
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
20-90
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Szu-Yuan Wu
Phone
+886910603955
Email
szuyuanwu5399@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu-Yuan Wu
Organizational Affiliation
Asia University, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Szu-Yuan Wu
City
Taipei
State/Province
Please Select
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Yuan Wu
Phone
0910603955
Email
szuyuanwu5399@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
study completed
IPD Sharing Time Frame
data will become available on April 30 2022.
IPD Sharing Access Criteria
requirement with official application
Learn more about this trial
Oligo-Fucoidan Decrease Lung Radiation Damage
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