Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Ototoxicity Measurement
研究概览
简要总结
RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.
PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.
详细描述
OBJECTIVES:
Primary
Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin.
Secondary
Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, 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
- •Diagnosis of cancer
- •Receiving therapeutic treatment with cisplatin
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Cognitively and physically able to participate in the study
- •Must be able to provide reliable behavioral threshold responses (patient must meet intra-session reliability criterion of +/- 5 dB)
- •At least 6 months since prior treatment with cisplatin or other ototoxic medications (e.g., aminoglycoside antibiotics)
- •At least 6 months since prior and no concurrent radiotherapy for head and neck tumors
- •Concurrent radiotherapy targeted below the neck allowed
- •More than 1 month since prior alpha-lipoic acid supplements
排除标准
- •No aggressive behavior as indicated in electronic chart notes
- •No documented dementia
- •No Alzheimer's disease
- •No severe psychosocial disorder
- •No active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance, or notes in patient chart
- •No renal disease
- •No Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart
- •Not receiving treatment for diabetes mellitus
- •No concurrent vincristine or vinblastine
- •No other concurrent investigational therapy
- •No other concurrent antioxidants or vitamin E > 100 IU per day
研究组 & 干预措施
Arm 1
Receiving alpha-lipoic acid during cisplatin treatment.
干预措施: alpha-lipoic acid (Drug)
Arm 1
Receiving alpha-lipoic acid during cisplatin treatment.
干预措施: Audiology (Behavioral)
Arm 1
Receiving alpha-lipoic acid during cisplatin treatment.
干预措施: laboratory biomarker analysis (Biological)
Arm 2
Receiving placebo during cisplatin treatment
干预措施: Audiology (Behavioral)
Arm 2
Receiving placebo during cisplatin treatment
干预措施: laboratory biomarker analysis (Biological)
Arm 2
Receiving placebo during cisplatin treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Ototoxicity Measurement
时间窗: Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.
Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement. ASHA criteria are defined as * 20 decibel (dB) increase at any test frequency, * 10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies.
次要结局
- Total Amount of Prescribed Cisplatin Dose Administered(cisplatin treatment period between 10 weeks and up to 16 weeks.)
- Malondialdehyde (MDA) Levels(Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.)