Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
Conditions
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. .
Interventions
PROCEDUREtranscranial magnetic stimulation
Undergo TMS
PROCEDUREelectromyography
Undergo EMG
OTHERsurvey administration
Ancillary studies
DRUGsunitinib malate
Given PO
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF) | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
transcranial magnetic stimulation: Undergo TMS
electromyography: Undergo EMG
survey administration: Ancillary studies
sunitinib malate: Given PO | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Age, Customized 40-49 years | 1 participants |
| Age, Customized 50-59 years | 5 participants |
| Age, Customized 60-69 years | 5 participants |
| Age, Customized 70-79 years | 2 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 12 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
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.
Time frame: Baseline and 28 days
Population: Data not collected
Primary
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.
Time frame: Baseline and 28 days
Population: Data not collected
Primary
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.
Time frame: Baseline and 28 days
Population: Data not collected