Trial Outcomes & Findings for Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer (NCT NCT01330446)

Last Updated: 2024-02-14

Results Overview

The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28 days. The range for BFI-Worst Fatigue AUC is from 0 to 280.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

26 participants

Primary outcome timeframe

4-6 weeks

Results posted on

2024-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Armodafinil 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.	Placebo 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.
Overall Study STARTED	13	13
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil n=13 Participants 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.	Placebo n=13 Participants 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants	11 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	13 participants n=4 Participants	26 participants n=27 Participants

PRIMARY outcome

Timeframe: 4-6 weeks

Population: The primary outcome measure is an item on a scale, i.e., has no units, the AUC also has no units.

Outcome measures

Outcome measures
Measure	Armodafinil n=8 Participants 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.	Placebo n=12 Participants 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.
Brief Fatigue Inventory-Worst	166.8 scores on a scale*day Interval 70.5 to 243.0	154.8 scores on a scale*day Interval 79.0 to 209.0

Adverse Events

Armodafinil

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Armodafinil n=13 participants at risk 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.	Placebo n=13 participants at risk 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. By mouth every morning for a 28 day cycle.
Psychiatric disorders Insomnia	15.4% 2/13 • Up to 30 days	0.00% 0/13 • Up to 30 days
Nervous system disorders Headache	0.00% 0/13 • Up to 30 days	15.4% 2/13 • Up to 30 days
Psychiatric disorders Anxiety	0.00% 0/13 • Up to 30 days	7.7% 1/13 • Up to 30 days
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Up to 30 days	15.4% 2/13 • Up to 30 days
Psychiatric disorders Mania	0.00% 0/13 • Up to 30 days	7.7% 1/13 • Up to 30 days
Psychiatric disorders Agitation	0.00% 0/13 • Up to 30 days	7.7% 1/13 • Up to 30 days
Renal and urinary disorders Urinary frequency	0.00% 0/13 • Up to 30 days	7.7% 1/13 • Up to 30 days

Additional Information

Dr. Gary B. Gunn

University of Texas M D Anderson Cancer Center

Phone: (713) 563-2562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place