Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

NCT01740154 | Terminated Results DMC

• 2 other identifiers: CASE8811NCI-2012-00988
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Supportive care (sunitinib malate, neuromuscular testing)

EXPERIMENTAL

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

Interventions

transcranial magnetic stimulation PROCEDURE

Undergo TMS

Also known as: TMS

Supportive care (sunitinib malate, neuromuscular testing)

electromyography PROCEDURE

Undergo EMG

Also known as: EMG

Supportive care (sunitinib malate, neuromuscular testing)

survey administration OTHER

Ancillary studies

Supportive care (sunitinib malate, neuromuscular testing)

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Supportive care (sunitinib malate, neuromuscular testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Fatigue; Carcinoma, Renal Cell

Interventions

Transcranial Magnetic Stimulation; Neurofeedback; Sunitinib

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Data not collected for outcomes.

Results Point of Contact

• Title: Dr. Brian Rini
• Organization: Case Comprehensive Cancer Center

rinib2@ccf.org

216-444-9567

Study Officials

• Brian Rini, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-11

Locations

US (1)