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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

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brian Rini, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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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 Posted: December 4, 2012    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Fatigue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action