Clinical trial NCT05616507: Oligo-Fucoidan Decrease Lung Radiation Damage
Official title: A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Toxicity
Keywords: radiation pneumonitis
fucoidan
radiation induced cardiac toxicity
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Asia University
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Radiation Pneumonitis
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Radiation Pneumonitis
timeFrame: one year
measure: Number of Participants With Radiation Pneumonitis
timeFrame: two year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Szu-Yuan Wu
state: Please Select
Study officials:
affiliation: Asia University, Taiwan
name: Szu-Yuan Wu
role: STUDY_DIRECTOR
References: