Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

NCT ID: NCT01740154

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-03-31

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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Conditions

Fatigue; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type: PROCEDURE

Undergo TMS

electromyography

Intervention Type: PROCEDURE

Undergo EMG

survey administration

Intervention Type: OTHER

Ancillary studies

sunitinib malate

Intervention Type: DRUG

Given PO

Interventions

transcranial magnetic stimulation

Undergo TMS

Intervention Type: PROCEDURE

electromyography

Undergo EMG

Intervention Type: PROCEDURE

survey administration

Ancillary studies

Intervention Type: OTHER

sunitinib malate

Given PO

Intervention Type: DRUG

Other Intervention Names

TMS; EMG; SU11248; sunitinib; Sutent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Rini, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2012-00988

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE8811

Identifier Type: -

Identifier Source: org_study_id