Oligo-Fucoidan Decrease Lung Radiation Damage

Radiation Toxicity Clinical Trial

— FIRILI  

Official title:

A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616507
• Other study ID #: IRB109-196-A
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2022
• Source: Taipei Medical University WanFang Hospital
• Contact: Szu-Yuan Wu
• Phone: +886910603955
• Email: szuyuanwu5399[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 rates of radiation therapy for lung cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Ages Eligible for Study: 20-90 years old

2. Men and women undergoing radiation therapy for lung cancer,no matter the radiation therapy is for curing or for palliating.

3. Karnofsky performance status,KPS > 70

4. Absolute Neutrophils > 1000/mm^3

5. Platelets > 75,000/mm^3

6. Hematocrit > 25%.

7. Liver and kidney function tests will be within normal range

8. Baseline blood pressure will be systolic > 110 mmHg sitting

Exclusion Criteria:

1. Patients who get lung cancer but no need or without the willingness of radiation therapy

2. Patients who are taking antiHTN drugs

3. Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant

4. Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)

5. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Related Conditions & MeSH terms

• Radiation Toxicity

Intervention

Dietary Supplement:
• fucoidan
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.

Locations

Country	Name	City	State
Taiwan	Szu-Yuan Wu	Taipei	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital	Asia University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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)	one year
Secondary	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)	two year