Clinical trial NCT01740154: 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
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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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

Primary outcomes:
measure: Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
timeFrame: Baseline and 28 days
measure: Change in EMG Amplitude and Power Frequency
timeFrame: Baseline and 28 days
measure: Changes in Motor Evoked Potential (MEP) by TMS
timeFrame: Baseline and 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Brian Rini, MD
role: PRINCIPAL_INVESTIGATOR
References: