Oligo-Fucoidan Decrease Lung Radiation Damage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2025-12-30

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.

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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.

Conditions

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Radiation Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fucoidan

Intervention Type DIETARY_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.

Arm B

observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No