Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Improvement in Neck Fibrosis
研究概览
简要总结
The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.
详细描述
The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life.
This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have evidence of neck fibrosis
- •previous radiation treatment to the neck for cancer
- •age greater than or equal to 18 years
- •life expectancy of greater than 12 weeks
- •ability to understand the purpose of the study and the willingness to sign a written informed consent document.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.
- •any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
研究组 & 干预措施
Topical Sodermix Dismutase
Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to applying Topical Sodermix Dismutase in the form of Sodermix(SOD) to the area of neck skin fibrosis twice a day for 12 weeks.
干预措施: Topical Sodermix Dismutase in the form of Sodermix (SOD) (Drug)
Placebo group
Cetaphil cream
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Neck Fibrosis
时间窗: 3 months
Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46.
次要结局
- Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients(From baseline to 3 months.)
- Cervical Spine Range of Motion(3 months)
- Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients(3 months)