Evaluation of Lactated Ringers for Protection From Cisplatin Ototoxicity.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pre-treatment audiogram will be compared with the post treatment audiogram. The differences between the two will be calculated and compared to the differences in the opposite ear.
研究概览
简要总结
The purpose of this study is to determine if Lactated Ringer's solution is effective in patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to cisplatin-induced hearing loss.
详细描述
About one-third of people who have been given Cisplatin, as part of their chemotherapy treatment, develop hearing loss. The purpose of this study is to determine if some degree of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To study this, patients will use drops in their ears; Lactated Ringer's will be placed in one ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop antibiotic will be placed in each ear at the same time. Each participant will receive a hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after the final treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients with cancer to be treated with cisplatin.
- •Patients expected to receive a minimum of 3 rounds of chemotherapy.
- •Patients receiving a minimum dose of cisplatin of 70 mg/m2
排除标准
- •Patients who have had middle ear surgery.
- •Patients who have active external or middle ear disease
- •Patients who have preceding pure tone average of >40 dB HL
研究组 & 干预措施
1
Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.
干预措施: Normal Saline and 0.3% ofloxacin (Drug)
2
Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.
干预措施: Lactated Ringer's with 0.03% Ofloxacin (Drug)
结局指标
主要结局
Pre-treatment audiogram will be compared with the post treatment audiogram. The differences between the two will be calculated and compared to the differences in the opposite ear.
时间窗: Patients will be enrolled in the study for 4-6 weeks from the initiation of therapy
次要结局
未报告次要终点
研究者
Dini Chissoe
Study Coordinator
University of Oklahoma