Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
研究概览
简要总结
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
详细描述
Objectives:
- To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.
- To evaluate feasibility and tolerability
Exploratory:
- To assess pain, symptom burden, functionality, and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven cancer of the head and neck cancer
- •Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
- •Planned primary or adjuvant radiation or chemoradiation therapy
- •Willing and able to provide informed consent
- •ECOG PS 0-2
- •Age ≥ 21 years
- •English speaking
排除标准
- •Currently on gabapentin or ketamine
- •Prior non-tolerance of gabapentin or ketamine
- •Unable to administer ketamine intranasally due to anatomical restrictions
- •History of seizure disorder
- •History of schizophrenia
- •History of increased intracranial pressure
- •Glomerular filtration rate <30 mL/min/1.73 m2
研究组 & 干预措施
Gabapentin plus Ketamine
Gabapentin and Ketamine will be taken 3 times per day.
干预措施: Gabapentin (Drug)
Gabapentin plus Ketamine
Gabapentin and Ketamine will be taken 3 times per day.
干预措施: Ketamine (Drug)
结局指标
主要结局
Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
时间窗: Approximately 28 days (Phase I)
Up to a maximum planned dose of 40 mg three times a day
Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
时间窗: Up to 30 post-treatment (Phase II)
Number of Participants With Grade 3 or 4 Adverse Events
次要结局
未报告次要终点
研究者
Natalie Lockney
Sponsor Investigator
Vanderbilt-Ingram Cancer Center