A Multicenter Randomized Phase II Clinical Trial of the Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Improvement in hearing threshold with sodium thiosulfate and mannitol administration
研究概览
简要总结
One common side effect of cisplatin chemotherapy is ototoxicity. The drugs sodium thiosulfate and mannitol may protect against cisplatin-induced hearing loss. Specifically, sodium thiosulfate has been found to protect the cells in the inner ear, and may therefore prevent hearing loss. Mannitol can help sodium thiosulfate enter the inner ear, and ponteially increase the effectiveness of sodium thiosulfate. This study aims to assess the efficacy of sodium thiosulfate and mannitol to reduce the hearing impairment caused by cisplatin chemotherapy.
详细描述
Randomized phase II clinical trial: with 1:1 randomization between cisplatin alone, and cisplatin + sodium thiosulfate and mannitol. Participants will first be recruited into a 2-year pilot feasibility study of 24 patients (12 in each arm). The pilot study will be performed to evaluate the feasibility of the trial as defined by the following factors: treatment outcomes, occurrence of adverse events, logistics of treatment delivery, as well as dropout and recruitment rates. The results from the pilot study will support the safety, efficacy, and effectiveness of the sodium thiosuldate and mannitol treatment, confirm feasibility using the factors mentioned above, and serve as an earlier-phase developmental function to enhance the probability of success of the subsequent clinical trial. Participants will complete various pre-treatment hearing tests. Participants will receive sodium thiosulfate and mannitol 4 - 8 hours following chemotherapy treatment. The control group will not receive the experimental intervention. Follow-up hearing tests will be performed at select time intervals following completion of their cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 undertaking systemic cisplatin therapy as part of their cancer treatment
- •Willing to provide informed consent
- •ECOG performance status 0-2
- •For female of child-bearing potential, a negative pregnancy test (beta-HCG) prior to study treatment is required
- •Any patient who is of reproductive age should provide written agreement to use adequate contraception for the duration of the trial
排除标准
- •Age less than 18
- •Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) (speech reception threshold >70dB, or word recognition score <50%) as confirmed with an audiogram
- •History of Meniere's or fluctuating hearing loss
- •Asymmetrical hearing loss (bone conduction threshold difference of: (a) 20 dB threshold difference at a single frequency, (b) 15 dB threshold difference at 2 frequencies, (c) 10 dB threshold difference at 3 frequencies
- •Abnormal renal function (creatinine clearance <60 ml/min)
- •Abnormal liver function (liver function tests (ALT and ALP) >2.5 times upper limit of normal without liver metastasis and >5 times upper limit of normal with liver metastasis
- •Previous hypersensitivity to STS or mannitol
- •Pregnant and/or nursing women
- •Patient unable to follow the protocol for any reason
研究组 & 干预措施
Standard Cisplatin-based Chemotherapy + Sodium Thiosulfate + Mannitol
Participants will receive the standard of care (cisplatin-based chemotherapy) plus the experimental treatment of Sodium Thiosulfate and Mannitol. Both drugs will be administered IV 4 - 8 hours following chemotherapy treatment, as part of post-chemotherapy hydration.
干预措施: Sodium Thiosulfate + Mannitol (Drug)
结局指标
主要结局
Improvement in hearing threshold with sodium thiosulfate and mannitol administration
时间窗: 2 months
The primary outcome measure of this study will be a comparison of hearing loss between the control and experimental groups. More specifically, each ear will be scored as having hearing loss if there is a greater than 10dB hearing loss in three contiguous frequencies. This will be measured via threshold hearing tests.
次要结局
- To assess the short and long-term adverse event reporting from combination of sodium thiosulfate, mannitol and cisplatin.(12 months)
- To monitor potential oncological impact of sodium thiosulfate and mannitol on overall survival(12 months)
- To monitor potential oncological impact of sodium thiosulfate and mannitol on disease free survival(12 months)
- To monitor potential oncological impact of sodium thiosulfate and mannitol on long-term renal clearance(12 months)