Ketamine Oral Rinse in the Management of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse.
研究概览
简要总结
This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment.
详细描述
Patients with histologically proven head and neck cancer undergoing radiation or concurrent chemoradiation as part of their treatment plan, will either receive ketamine oral rinse or unmedicated oral rinse to use 4 times a day if they develop oral mucositis during their radiation.
Patients will be monitored during treatment and up to 30 days after and will utilize a pain diary to document daily.
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
- Single (Participant)
盲法说明
The principal investigator and pharmacist will be the only ones who are aware of whom gets which arm of the study.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure.
- •At least 18 years-of-age at the time of signature of the informed consent form (ICF).
- •Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or
- •The patients has received at least one radiation treatment for (HNSCC) the current disease.
- •CTCAE v. 5.0 grade 2 or greater oral cavity or pharyngeal mucositis documented to have developed after initiation of radiotherapy.
- •Males or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Male patients must also refrain from donating sperm during participation in the study.
排除标准
- •Inability to sign an informed consent form.
- •Any other malignancy diagnosed or treated within 10 years prior to enrollment.
- •Any documented hypersensitivity to ketamine.
- •Contraindication for ketamine use, including allergy.
- •Patients with schizophrenia, acute psychosis, or any psychiatric disorder that could be dangerous if exacerbated.
- •Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least <<6>> months after the last administration of study treatment.
- •Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.
- •As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- •Patients with a prior or concurrent malignancy whole natural history or treatment does not have potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
研究组 & 干预措施
Control Group
Topical unmedicated syrup base + any standard treatment for oral mucositis.
干预措施: Placebo (Drug)
Intervention Group
Topical ketamine in syrup + any standard treatment for oral mucositis.
干预措施: Ketamine Topical (Drug)
结局指标
主要结局
Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse.
时间窗: 6 months
Review weekly questionnaires of patients who received ketamine oral rinse to assess if it helped with the pain of mucositis caused by the radiation in head and neck cancer patients.
次要结局
- Number of patients whose dysphagia was decreased by the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.(6 months.)
- Number of patients whose quality-of-life increased after the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.(6 months)
- Number of patients who need morphine prescription equivalent reductions as a result of using ketamine oral rinse.(6 months)