CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Armodafinil +3 moredrug
Likely dose
Armodafinil 150 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.

Search/NCT01746043
NCT01746043Phase 2Completed

A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

M.D. Anderson Cancer Center·interventional·Posted Dec 10, 2012·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating Armodafinil, Placebo, and 2 other interventions for Esophageal Cancer. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness). Armodafinil is designed to prevent excessive sleepiness. Minocycline is an antibiotic, which may help to reduce multiple symptoms. In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2012
Enrollment StartFeb 1, 2013
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.6 years ago

Interventions

Armodafinildrug

150 mg by mouth once a day for 6 weeks.

Placeboother

1 capsule by mouth 2 times a day for 6 weeks.

Minocyclinedrug

100 mg by mouth 2 times a day for 6 weeks.

Questionnairesbehavioral

Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.