Oligo-Fucoidan Decrease Lung Radiation Damage

Not Applicable

Recruiting

• Conditions: Radiation Toxicity
• Interventions: Dietary Supplement: fucoidan

• Registration Number: NCT05616507
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

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

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 Timeline

• Study Start: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-11-13
• Last Update Submitted: 2022-11-13
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Radiation Pneumonitis	6 months	The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Radiation Pneumonitis	two year	The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)(Grade 0-5)

Trial Locations

Locations (1)

Szu-Yuan Wu; 🇨🇳 Taipei, Please Select, Taiwan