Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
18 Years
N/A
Both
Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
Trial Information
Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
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.
.
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 or any hearing
problems
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Changes of muscular (peripheral) fatigue maximal twitch force (MTF)
Outcome 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.
Outcome Time Frame:
Baseline and 28 days
Safety Issue:
No
Principal Investigator
Mellar Davis, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CASE8811
NCT ID:
NCT01740154
Start Date:
September 2012
Completion Date:
Related Keywords:
- Fatigue
- Recurrent Renal Cell Cancer
- Stage IV Renal Cell Cancer
- Carcinoma, Renal Cell
- Fatigue
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
