Trial Outcomes & Findings for Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer (NCT NCT01740154)

Last Updated: 2018-12-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Baseline and 28 days

Results posted on

2018-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. transcranial magnetic stimulation: Undergo TMS electromyography: Undergo EMG survey administration: Ancillary studies sunitinib malate: Given PO
Overall Study Adverse Event	1

Baseline Characteristics

Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (Sunitinib Malate, Neuromuscular Testing) n=13 Participants 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
Age, Customized 40-49 years	1 participants n=5 Participants
Age, Customized 50-59 years	5 participants n=5 Participants
Age, Customized 60-69 years	5 participants n=5 Participants
Age, Customized 70-79 years	2 participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: Data not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: Data not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: Data not collected

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.

Outcome measures

Outcome data not reported

Adverse Events

Supportive Care (Sunitinib Malate, Neuromuscular Testing)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Supportive Care (Sunitinib Malate, Neuromuscular Testing) n=13 participants at risk 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
General disorders Pain	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Supportive Care (Sunitinib Malate, Neuromuscular Testing) n=13 participants at risk 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
General disorders Fatigue	92.3% 12/13 • Number of events 16

Additional Information

Dr. Brian Rini

Case Comprehensive Cancer Center

Phone: 216-444-9567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place