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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Fatigue
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Procedure: transcranial magnetic stimulation
Procedure: electromyography
Other: survey administration
Drug: sunitinib malate
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
Patients accrued on study
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
40-49 years 1
50-59 years 5
60-69 years 5
70-79 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
3
  23.1%
Male
10
  76.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
1
   7.7%
Not Hispanic or Latino
12
  92.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
Hide Description 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.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description:

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in EMG Amplitude and Power Frequency
Hide Description 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.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description:

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Changes in Motor Evoked Potential (MEP) by TMS
Hide Description 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.
Time Frame Baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description:

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Hide Arm/Group Description

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.

transcranial magnetic stimulation: Undergo TMS

electromyography: Undergo EMG

survey administration: Ancillary studies

sunitinib malate: Given PO

All-Cause Mortality
Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Affected / at Risk (%)
Total   0/13 (0.00%)    
Hide Serious Adverse Events
Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Affected / at Risk (%) # Events
Total   1/13 (7.69%)    
General disorders   
Pain * 1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Supportive Care (Sunitinib Malate, Neuromuscular Testing)
Affected / at Risk (%) # Events
Total   12/13 (92.31%)    
General disorders   
Fatigue * 1  12/13 (92.31%)  16
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brian Rini
Organization: Case Comprehensive Cancer Center
Phone: 216-444-9567
EMail: rinib2@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01740154    
Other Study ID Numbers: CASE8811
NCI-2012-00988 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 30, 2012
First Posted: December 4, 2012
Results First Submitted: June 27, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018