Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes of muscular (peripheral) fatigue maximal twitch force (MTF)
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.
Baseline and 28 days
Mellar Davis, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|