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

NCT01330446 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-14

Study results available
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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.

Conditions

Interventions

DRUG

Armodafinil

50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.

OTHER

Placebo

1 by mouth every morning for a 28 day cycle.

BEHAVIORAL

Questionnaires

Series of questionnaires completed at different time points before, during, and at study completion.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gary B. Gunn, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-19
Primary Completion
2022-12-08
Completion
2022-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330446 on ClinicalTrials.gov