Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
研究概览
简要总结
The purpose of this research study is to determine how sunitinib (sunitinib malate) causes fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their levels of fatigue every two weeks while they are participating in this research study. The questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of physical measurements for fatigue will be performed before the first dose of sunitinib and again (4) weeks later to see if there are any changes in physical level of fatigues
详细描述
PRIMARY OBJECTIVES:
I. To determine the mechanisms associated with sunitinib related fatigue by recording EMG signals during a submaximal elbow contraction, twitch force and TMS prior to and at the end of 4 weeks of sunitinib in metastatic RCC patients.
OUTLINE:
Patients receive sunitinib malate orally (PO) daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Histologically proven renal cell cancer with metastases; pathology from either primary or metastatic tumor; no histologic subtype restriction
- •Evidence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or evaluable disease
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
- •Hemoglobin >= 9 gram/dL
- •Common Terminology Criteria for Adverse Events (CTCAE) fatigue levels pre-treatment < 2
- •Signed and dated informed consent
排除标准
- •Greater than 2 previous systemic treatments for RCC
- •Heart failure, New York Heart Association (NYHA) class 3 and 4
- •Unstable angina (defined as ongoing use of nitrates or cardiac ischemia in the prior 6 months)
- •Arrhythmia uncontrolled by medication
- •Hypertension (> 160/90 mmHg) not controlled with medical management
- •Brain metastases or previous cranial radiation, leptomeningeal cancer
- •Surgery within 2 weeks of study entrance
- •History of stroke, myasthenia gravis, multiple sclerosis, polyneuropathy
- •Pregnancy or breast feeding
- •Central-nervous system active medications, intake or withdrawal of which lowers seizure threshold (determination made in consultation with study's responsible treating physician)
- •Any history of epilepsy, convulsion or seizure
- •Medication-resistant epilepsy in a first-degree relative
- •Cochlear implants or internal pulse generators or cardiac pacemakers or intracardiac lines
- •Metallic implants in the vicinity of discharging coil in the head or cervical spine
- •Unexplained fainting spells/syncope or multiple concussions
- •History of severe head trauma (followed by loss of consciousness)
- •Implanted brain or spinal cord electrodes/stimulation
- •Medication infusion device
- •Frequent/severe headaches or severe migraines
- •Past or current medical history of diagnosed or undiagnosed tinnitus
研究组 & 干预措施
Supportive care (sunitinib malate, neuromuscular testing)
Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
干预措施: transcranial magnetic stimulation (Procedure)
Supportive care (sunitinib malate, neuromuscular testing)
Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
干预措施: electromyography (Procedure)
Supportive care (sunitinib malate, neuromuscular testing)
Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
干预措施: survey administration (Other)
Supportive care (sunitinib malate, neuromuscular testing)
Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
时间窗: Baseline and 28 days
The MTF will be elicited by supramaximal-intensity electrical stimulation of the muscle before and after the sustained contraction (SC). If the muscle is fatigued at the end of the SC, the MTF will be reduced because the ability of muscle to generate force declines with fatigue. If the sunitinib treatment results in minimal muscular fatigue, the MTF will not have as much reduction in the 2nd as that in the 1st session.
Change in EMG Amplitude and Power Frequency
时间窗: Baseline and 28 days
EMG amplitude will increase (for low-intensity SC) and mean power frequency (MPF) decrease with muscle fatigue. The EMG signals recorded during the SC, its amplitude and MPF will be analyzed to determine their changes at the end vs. beginning of the SC. If the sunitinib results in minimal muscular fatigue, the amount of EMG increase and MPF decrease will be reduced in the 2nd compared with those the 1st session.
Changes in Motor Evoked Potential (MEP) by TMS
时间窗: Baseline and 28 days
TMS illustrates the changes in corticospinal excitability occurring in association with fatigue. Central muscle evoked response (MEP) will be elicited using transcranial magnetic stimulation (TMS) using single stimulus pulses applied to the scalp overlying the primary motor cortex.
次要结局
未报告次要终点