Transtympanic Sodium Thiosulfate to Prevent Cisplatin-related Hearing Loss A Randomized Controlled Multicenter Phase III Trial; The SOUND Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- The efficacy (clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity.
研究概览
简要总结
The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. The main question it aims to answer is:
Researchers will compare the ear treated with STS gel to the untreated ear within the same patient to see if STS prevents hearing loss.
Participants will:
- Receive STS gel injections into the middle ear of one ear (randomized) within 3 hours before each cisplatin infusion (3-7 injections per patient).
- Undergo hearing tests at baseline and 2-4 months after the last cisplatin treatment.
- Complete questionnaires about hearing and tinnitus at baseline and 2-4 months after treatment.
详细描述
Trial design:
This study is an investigator-initiated randomized controlled multicenter phase III trial. Patient accrual and treatment (treatment and hearing analysis will take 22 weeks per patient) will start in 2025 and will be completed in 2028. Afterwards, the patients will have a routine follow-up for a median of 2 years to collect necessary survival data (2025-2030).
Trial population:
A hundred patients with solid head and neck malignancies who are treated with ≥ 200 mg/m2 cisplatin will be included. To be eligible for participation, patients must be 18 years or older. Study participation is not possible if more than 30 gray radiotherapy is applied to the inner ear, asymmetric hearing loss or more than 40 dB hearing loss is detected before start of treatment, known hypersensitivity to STS injections, and/or if patients have ear conditions that prevent middle ear injections from being administered properly.
Interventions:
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
- •Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2
- •Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles
- •Able and willing to give written informed consent;
- •WHO performance status of 0, 1 or 2;
- •Age older than 18 years.
排除标准
- •Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).
- •Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
- •A planned radiation dose of > 30 Gy to the cochlea (8);
- •Known hypersensitivity to STS-containing HYA gel formulation;
- •Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;
- •Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.
研究组 & 干预措施
Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate
One ear of a patient: The transtympanic sodium thiosulphate is administered into one ear of a patient. The intervention takes place within 3 hours before each cisplatin course. The intervention takes place 3 to 7 times, depending on the cisplatin schedule
干预措施: Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate (Drug)
结局指标
主要结局
The efficacy (clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity.
时间窗: Baseline and 2-4 months after last cycle of chemotherapy
The percent of patients with a clinically relevant benefit of transtympanic STS injection against CIHL, defined as the change in the threshold between baseline and 3 months after treatment differs by ≥ 10 dB at any three adjacent frequencies from 0.5 to 16 kHz in favour of the STS treated ear.
次要结局
- Survival(1 and 2 years after the start of treatment.)
- The superiority of STS versus untreated ear with regard to hearing capacity based on audiometry.(Baseline and 2-4 months after last cycle of chemotherapy)
- The superiority of STS versus untreated ear with regard to hearing loss based on American Speech-Language-Hearing Association criteria (ASHA).(Baseline and 2-4 months after last cycle of chemotherapy)
- The superiority of STS versus untreated ear with regard to hearing loss based on TUNE criteria.(Baseline and 2-4 months after last cycle of chemotherapy)
- The superiority of STS versus placebo-treated ear with regard to hearing loss based on the Common Terminology Criteria for Adverse Eventes (CTCAE) criteria.(Baseline and 2-4 months after last cycle of chemotherapy.)
- Quality of life/Patient-related outcome measures (PROM). Subjective hearing loss after platinum treatment.(Baseline and 2-4 months after last cycle of chemotherapy)
- Quality of life/Patient-related outcome measures (PROM). Subjective tinnitus after platinum treatment.(Baseline and 2-4 months after last cycle of chemotherapy)