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| Name | Class |
|---|---|
| Asia University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm B | No Intervention | observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fucoidan | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | one year |
| Number of Participants With Radiation Pneumonitis |
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Inclusion Criteria:
Exclusion Criteria:
20-90
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szu-Yuan Wu | Contact | +886910603955 | szuyuanwu5399@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Szu-Yuan Wu | Asia University, Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szu-Yuan Wu | Recruiting | Taipei | Please Select | 116 | Taiwan |
study completed
data will become available on April 30 2022.
requirement with official application
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D017564 | Radiation Pneumonitis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C007789 | fucoidan |
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Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
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|
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)(Grade 0-5) |
| two year |
| D055370 | Lung Injury |