Clincosm LogoSign in Get a demo

FIRILI: Oligo-Fucoidan Decrease Lung Radiation Damage

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05616507
Collaborator
Asia University (Other)
100
Enrollment
1
Location
2
Arms
45
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: fucoidan
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance statusStudy Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
Actual Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: 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.
No Intervention: Arm B

observation

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Number of Participants With Radiation Pneumonitis [one year]

    The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) (Grade 0-5)

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Szu-Yuan Wu Taipei Please Select Taiwan 116

Sponsors and Collaborators

  • Taipei Medical University WanFang Hospital
  • Asia University

Investigators

  • Study Director: Szu-Yuan Wu, Asia University, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT05616507
Other Study ID Numbers:
  • IRB109-196-A
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Taipei Medical University WanFang Hospital
radiation pneumonitis
fucoidan
radiation induced cardiac toxicity
Additional relevant MeSH terms:
Fucoidan

Study Results

No Results Posted as of Nov 15, 2022