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Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Results First Submitted Date  ICMJE June 27, 2018
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • 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-EEG 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
Official Title  ICMJE Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
Brief Summary 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
Detailed Description

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.

.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Fatigue
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
Intervention  ICMJE
  • Procedure: transcranial magnetic stimulation
    Undergo TMS
    Other Name: TMS
  • Procedure: electromyography
    Undergo EMG
    Other Name: EMG
  • Other: survey administration
    Ancillary studies
  • Drug: sunitinib malate
    Given PO
    Other Names:
    • SU11248
    • sunitinib
    • Sutent
Study Arms  ICMJE 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.
Interventions:
  • Procedure: transcranial magnetic stimulation
  • Procedure: electromyography
  • Other: survey administration
  • Drug: sunitinib malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 23, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
28
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740154
Other Study ID Numbers  ICMJE CASE8811
NCI-2012-00988 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Brian Rini, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP