Oligo-Fucoidan Decrease Lung Radiation Damage (FIRILI)

Taipei Medical University

Status: Enrolling

Conditions: Radiation Toxicity

Treatments: Dietary Supplement: fucoidan

Study type: Interventional

Funder types: Other

Identifiers

NCT05616507

IRB109-196-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm A

Experimental group

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.

Treatment:

Dietary Supplement: fucoidan

Arm B

No Intervention group

Description:

observation