Trial Outcomes & Findings for Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery (NCT NCT02767388)

Last Updated: 2023-09-29

Results Overview

Response time - measured as the time required to respond to a target hidden among distractor items - is the primary outcome measure of the capture task. Proportional response time was calculated by subtracting mean response time in the neutral condition from response time in the capture condition, and dividing that number by the standard deviation of response time across conditions. Changes in proportional response time across study visits is reported. Positive values correspond to an increase in response time and negative values correspond to a decrease in response time.

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Results posted on

2023-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	HM - Chemotherapy Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls Study participants that are demographically matched to HM study patients and meet all inclusion criteria
Overall Study STARTED	15	15	15
Overall Study COMPLETED	8	10	12
Overall Study NOT COMPLETED	7	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HM - Chemotherapy n=15 Participants Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy n=15 Participants Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls n=15 Participants Study participants that are demographically matched to HM study patients and meet all inclusion criteria	Total n=45 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 15.2 • n=5 Participants	63.2 years STANDARD_DEVIATION 10.9 • n=7 Participants	60.0 years STANDARD_DEVIATION 16.5 • n=5 Participants	60.6 years STANDARD_DEVIATION 14.5 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	45 participants n=4 Participants

PRIMARY outcome

Timeframe: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Population: The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.

Outcome measures

Outcome measures
Measure	HM - Chemotherapy n=8 Participants Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy n=11 Participants Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls n=12 Participants Study participants that are demographically matched to HM study patients and meet all inclusion criteria
Change From Baseline Capture Task Performance at 1- and 3- Months Change at 1-Month	.103 change in proportional response time Standard Deviation .223	-.039 change in proportional response time Standard Deviation .190	.066 change in proportional response time Standard Deviation .201
Change From Baseline Capture Task Performance at 1- and 3- Months Change at 3-Month	.067 change in proportional response time Standard Deviation .113	-.002 change in proportional response time Standard Deviation .191	-.084 change in proportional response time Standard Deviation .165

PRIMARY outcome

Timeframe: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Population: Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.

Electrophysiological component that measures allocation of attentional resources

Outcome measures

Outcome measures
Measure	HM - Chemotherapy n=7 Participants Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy n=10 Participants Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls n=11 Participants Study participants that are demographically matched to HM study patients and meet all inclusion criteria
Change From Baseline N2pc Amplitude at 1- and 3- Months Change at 1-Month	.47 microvolts Standard Deviation .77	-.02 microvolts Standard Deviation .55	-.34 microvolts Standard Deviation .54
Change From Baseline N2pc Amplitude at 1- and 3- Months Change at 3-Month	.41 microvolts Standard Deviation 1.00	.36 microvolts Standard Deviation .96	-.63 microvolts Standard Deviation .60

PRIMARY outcome

Timeframe: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Response accuracy - measured as the proportion of correct trials - is the primary outcome measure of the filter task. Changes in response accuracy were calculated by subtracting response accuracy at 1-month and 3-months from baseline response accuracy. Positive values correspond to an increase in accuracy and negative values correspond to a decline in accuracy.

Outcome measures

Outcome measures
Measure	HM - Chemotherapy n=8 Participants Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy n=11 Participants Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls n=11 Participants Study participants that are demographically matched to HM study patients and meet all inclusion criteria
Change From Baseline Filter Task Performance at 1- and 3- Months Change at 1-Month	-.013 change in proportion of correct trials Standard Deviation .04	.011 change in proportion of correct trials Standard Deviation .027	-.004 change in proportion of correct trials Standard Deviation .034
Change From Baseline Filter Task Performance at 1- and 3- Months Change at 3-Month	.002 change in proportion of correct trials Standard Deviation .031	-.006 change in proportion of correct trials Standard Deviation .025	-.006 change in proportion of correct trials Standard Deviation .028

PRIMARY outcome

Timeframe: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Electrophysiological component that measures online storage load

Outcome measures

Outcome measures
Measure	HM - Chemotherapy n=7 Participants Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.	HM - No Chemotherapy n=9 Participants Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.	Healthy Controls n=11 Participants Study participants that are demographically matched to HM study patients and meet all inclusion criteria
Change From Baseline CDA Amplitude at 1- and 3- Months Change at 3-Month	-.34 microvolts Standard Deviation .43	-.10 microvolts Standard Deviation .87	-.27 microvolts Standard Deviation .77
Change From Baseline CDA Amplitude at 1- and 3- Months Change at 1-Month	.30 microvolts Standard Deviation .29	-.22 microvolts Standard Deviation .91	-.09 microvolts Standard Deviation .55

Adverse Events

HM - Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HM - No Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Anderson

University of Nebraska Medical Center

Phone: 402-559-6870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place