Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

Fatigue Clinical Trial

Official title:

Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01740154
• Other study ID #: CASE8811
• Secondary ID: NCI-2012-00988
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• transcranial magnetic stimulation
Undergo TMS
• electromyography
Undergo EMG

Other:
• survey administration
Ancillary studies

Drug:
• sunitinib malate
Given PO

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 28 days
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.	Baseline and 28 days
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.	Baseline and 28 days