Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT01740154|
Recruitment Status : Terminated (Slow Accrual)
First Posted : December 4, 2012
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer||Procedure: transcranial magnetic stimulation Procedure: electromyography Other: survey administration Drug: sunitinib malate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: 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.
Procedure: transcranial magnetic stimulation
Other Name: TMS
Other Name: EMG
Other: survey administration
Drug: sunitinib malate
- Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740154
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Brian Rini, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|