NCT05616507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 15, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

April 7, 2022

Last Update Submit

November 13, 2022

Conditions

Radiation Toxicity

Keywords

radiation pneumonitisfucoidanradiation induced cardiac toxicity

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months

Secondary Outcomes (2)

  • Number of Participants With Radiation Pneumonitis

    one year

  • Number of Participants With Radiation Pneumonitis

    two year

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

NO INTERVENTION

observation

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.

Arm A

Eligibility Criteria

Age20 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details20-90
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages Eligible for Study: 20-90 years old
  • Men and women undergoing radiation therapy for lung cancer，no matter the radiation therapy is for curing or for palliating.
  • Karnofsky performance status，KPS \> 70
  • Absolute Neutrophils \> 1000/mm\^3
  • Platelets \> 75,000/mm\^3
  • Hematocrit \> 25%.
  • Liver and kidney function tests will be within normal range
  • Baseline blood pressure will be systolic \> 110 mmHg sitting

You may not qualify if:

  • Patients who get lung cancer but no need or without the willingness of radiation therapy
  • Patients who are taking antiHTN drugs
  • Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
  • Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
  • Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szu-Yuan Wu

Taipei, Please Select, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Radiation InjuriesRadiation Pneumonitis

Interventions

fucoidan

Condition Hierarchy (Ancestors)

Wounds and InjuriesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung Injury

Study Officials

  • Szu-Yuan Wu

    Asia University, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Szu-Yuan Wu

CONTACT

+886910603955szuyuanwu5399@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

November 15, 2022

Study Start

March 30, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

November 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

study completed

Shared Documents
STUDY PROTOCOL
Time Frame
data will become available on April 30 2022.
Access Criteria
requirement with official application

Locations

TW(1)