FatigueNCT01740154
Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
A study testing transcranial magnetic stimulation, electromyography and survey administration in people with Fatigue and Recurrent Renal Cell Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
- What is being tested?
- transcranial magnetic stimulation, electromyography and survey administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
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
Read the 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.
.
- Being tested
- transcranial magnetic stimulation, electromyography, survey administration, sunitinib malate
- Medical subject headings
- Fatigue, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationProcedure or surgery
Also called TMS
Undergo TMS
electromyographyProcedure or surgery
Also called EMG
Undergo EMG
survey administrationOther
Ancillary studies
sunitinib malateDrug
Also called SU11248, sunitinib, Sutent
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: transcranial magnetic stimulation; Procedure: electromyography; Other: survey administration; Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Rini, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740154
- Sponsor's protocol ID
- CASE8811
- Other IDs
- NCI-2012-00988
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2012
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Neuromuscular Mechanisms Associated With Sunitinib Related Fatigue
- ClinicalTrials.gov ID
- NCT01740154
- Acronym / sponsor ID
- CASE8811
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 6 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (sunitinib malate, neuromuscular testing) | Experimental | Procedure: transcranial magnetic stimulation, Procedure: electromyography, Other: survey administration, Drug: sunitinib malatePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationAlso: TMSUndergo TMS | Procedure or surgery | Supportive care (sunitinib malate, neuromuscular testing) |
| electromyographyAlso: EMGUndergo EMG | Procedure or surgery | Supportive care (sunitinib malate, neuromuscular testing) |
| survey administrationAncillary studies | Other | Supportive care (sunitinib malate, neuromuscular testing) |
| sunitinib malateAlso: SU11248, sunitinib, SutentGiven PO | Drug | Supportive care (sunitinib malate, neuromuscular testing) |
Primary outcome
Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Rini, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation, electromyography and survey administration in people with Fatigue and Recurrent Renal Cell Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF) (time frame: Baseline and 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.