Oligo-Fucoidan Decrease Lung Radiation Damage

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radiation Toxicity

Intervention / Treatment
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* Dietary Supplement: fucoidan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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<br>* 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.<br>|
| No Intervention: Arm B<br>observation | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation pneumonitis, fucoidan, radiation induced cardiac toxicity