Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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.
.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: transcranial magnetic stimulation
Undergo TMS
Other Names:
Procedure: electromyography
Undergo EMG
Other Names:
Other: survey administration
Ancillary studies
Drug: sunitinib malate
Given PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF) [Baseline and 28 days]
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.
- Change in EMG Amplitude and Power Frequency [Baseline and 28 days]
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.
- Changes in Motor Evoked Potential (MEP) by TMS [Baseline and 28 days]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Brian Rini, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE8811
- NCI-2012-00988
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO |
| Period Title: Overall Study | |
| STARTED | 13 |
| COMPLETED | 12 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO |
| Overall Participants | 13 |
| Age, Customized (participants) [Number] | |
| 40-49 years |
1
7.7%
|
| 50-59 years |
5
38.5%
|
| 60-69 years |
5
38.5%
|
| 70-79 years |
2
15.4%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
23.1%
|
| Male |
10
76.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
7.7%
|
| Not Hispanic or Latino |
12
92.3%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
13
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
13
100%
|
Outcome Measures
| Title | Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF) |
|---|---|
| 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. |
| Time Frame | Baseline and 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not collected |
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO |
| Measure Participants | 0 |
| Title | Change in EMG Amplitude and Power Frequency |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not collected |
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO |
| Measure Participants | 0 |
| Title | Changes in Motor Evoked Potential (MEP) by TMS |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not collected |
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) |
|---|---|
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Supportive Care (Sunitinib Malate, Neuromuscular Testing) | |
| Arm/Group Description | 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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO | |
All Cause Mortality |
||
| Supportive Care (Sunitinib Malate, Neuromuscular Testing) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | |
Serious Adverse Events |
||
| Supportive Care (Sunitinib Malate, Neuromuscular Testing) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/13 (7.7%) | |
| General disorders | ||
| Pain | 1/13 (7.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Supportive Care (Sunitinib Malate, Neuromuscular Testing) | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/13 (92.3%) | |
| General disorders | ||
| Fatigue | 12/13 (92.3%) | 16 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Brian Rini |
|---|---|
| Organization | Case Comprehensive Cancer Center |
| Phone | 216-444-9567 |
| rinib2@ccf.org |
- CASE8811
- NCI-2012-00988