Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain caused by oral mucositis
研究概览
简要总结
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.
详细描述
The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these 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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have definitive diagnosis of head and neck cancer.
- •Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer.
- •Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- •Absence of life limiting medical conditions
- •Ability to understand and willingness to sign a written informed consent document.
- •ECOG performance status 0, 1, or 2 (Karnofsky > 60%).
- •Patients must have adequate bone marrow function. ANC > 1000/microL and Platelet count >100,000/microL
- •Age >20 years
排除标准
- •Known familial head and neck cancer syndrome
- •Pregnancy
- •Known HIV
- •Patients receiving immunosuppressive drugs
- •Inflammatory bowel disease
- •Active second malignancy in the last 5 years
- •Patients receiving any other investigational agent(s)
- •Patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer
研究组 & 干预措施
1 - Grape extract
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
干预措施: Grape extract (Dietary Supplement)
2 - Lortab, Fentanyl patch, mouthwash
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
干预措施: Lortab, Fentanyl patch, mouthwash (Drug)
结局指标
主要结局
Pain caused by oral mucositis
时间窗: Total followup of six months
Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
次要结局
- Level of immune biomarkers in blood(Within three days of the completion of radiation therapy which will last approximately 30 days.)
- Level of immune biomarkers in mucosal tissue(Within three days of the completion of radiation therapy which will last approximately thirty days.)
研究者
Rebecca Redman
Associate Professor
University of Louisville