Oligo-Fucoidan Decrease Lung Radiation Damage (FIRILI)

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Toxicity
• Intervention / Treatment: Dietary supplement: fucoidan

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Szu-Yuan Wu; Phone Number: +886910603955; Email: szuyuanwu5399@gmail.com

Study Locations

• Taiwan
  • Please Select
    • Taipei, Please Select, Taiwan, 116
      • Recruiting
      • Szu-Yuan Wu
      • Contact: Szu-Yuan Wu; Phone Number: 0910603955; Email: szuyuanwu5399@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; 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.	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.
No Intervention: Arm B; observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Asia University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: radiation pneumonitis; fucoidan; radiation induced cardiac toxicity
• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Anticoagulants; Anti-Ulcer Agents; Fucoidan
• Other Study ID Numbers: IRB109-196-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study completed
• IPD Sharing Time Frame: data will become available on April 30 2022.
• IPD Sharing Access Criteria: requirement with official application
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• 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