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Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

Primary Purpose

Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial magnetic stimulation
electromyography
survey administration
sunitinib malate
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (sunitinib malate, neuromuscular testing)

Arm 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.

Outcomes

Primary Outcome Measures

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.
Change in EMG Amplitude and Power Frequency
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2012
Last Updated
November 14, 2018
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01740154
Brief Title
Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
Official Title
Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
September 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (sunitinib malate, neuromuscular testing)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
transcranial magnetic stimulation
Other Intervention Name(s)
TMS
Intervention Description
Undergo TMS
Intervention Type
Procedure
Intervention Name(s)
electromyography
Other Intervention Name(s)
EMG
Intervention Description
Undergo EMG
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
SU11248, sunitinib, Sutent
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
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
Title
Change in EMG Amplitude and Power Frequency
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
Title
Changes in Motor Evoked Potential (MEP) by TMS
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Rini, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

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