A Phase II Trial of Oligo-Fucoidan in Radiation Induced Ling Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Radiation Pneumonitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm B
observation
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.
干预措施: fucoidan (Dietary Supplement)
结局指标
主要结局
Number of Participants With Radiation Pneumonitis
时间窗: 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)
次要结局
- Number of Participants With Radiation Pneumonitis(two year)
- Number of Participants With Radiation Pneumonitis(one year)