Oligo-Fucoidan Decrease Lung Radiation Damage

Taipei Medical University WanFang Hospital100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Radiation Toxicity

Interventions

fucoidanDIETARY_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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Szu-Yuan Wu

Taipei, Please Select, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 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)

Time frame: two year

Central Contacts

Szu-Yuan Wu

CONTACT

+886910603955 szuyuanwu5399@gmail.com

Data from ClinicalTrials.gov

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