At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
Armodafinil +2 moredrug
Likely dose
Armodafinil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
In Brief
A Phase 2 clinical trial evaluating Armodafinil, Placebo, and 1 other intervention for Head And Neck Cancer and Fatigue. Completed, enrolled 26 participants across 2 sites.
Detailed Summary
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead And Neck Cancer, Fatigue
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionDec 2022
TodayJul 2026
First PostedApr 7, 2011
Enrollment StartMay 19, 2011
Primary CompletionDec 8, 2022
TodayJul 2, 2026
Enrollment to primary: 11.6 yearsPosted 15.2 years ago
Interventions
Armodafinildrug
50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
Placeboother
1 by mouth every morning for a 28 day cycle.
Questionnairesbehavioral
Series of questionnaires completed at different time points before, during, and at study completion.