An interventional study of transcranial magnetic stimulation and electromyography in Fatigue, Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, sponsored by Case Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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
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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1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 13 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
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Exclusion Criteria:
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 · Procedure: electromyography · Other: survey administration · Drug: sunitinib malate
Undergo TMS
Also known as: TMS
Undergo EMG
Also known as: EMG
Ancillary studies
Given PO
Also known as: SU11248, sunitinib, Sutent
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
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
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
| Milestone | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Sunitinib Malate, Neuromuscular Testing) | 0/13 (0%) | 1/13 (7.7%) | 12/13 (92.3%) |
| Event | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| PainGeneral disorders | 1/13 |
| Event | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| FatigueGeneral disorders | 12/13 |
Patients accrued on study
| Age, Customized(participants) | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| 40-49 years | 1 |
| 50-59 years | 5 |
| 60-69 years | 5 |
| 70-79 years | 2 |
| Sex: Female, Male(Participants) | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Female | 3 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| United States | 13 |
This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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