Status:
COMPLETED
Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors.
Detailed Description
If you agree to take part in this study, the following tests and procedures will be performed: * Blood (about 3 teaspoons) will be drawn to test for markers of inflammation and to test for genes rela...
Eligibility Criteria
Inclusion
- Male patients at least 18 years old.
- Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months.
- Patients who speak English.
- Patients who are willing and able to review, understand, and provide written consent.
- Patients who agree to comply with all study procedures.
Exclusion
- Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator.
- Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
- Patients with major depressive disorder or severe depression (a score of 22 or greater on the Center for Epidemiologic Studies Depression (CES-D)); for scores of 16 or higher, we will notify the patient's treating physician within 1 working day of the screening to allow for appropriate management or referral.
- Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate.
- Patients who are enrolled and receiving active treatment in a symptom intervention trial or who are in the treatment phase of a clinical trial.
- Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the time of screening.
- Patients who cannot distinguish between the red and blue stimuli of the set-switch task.
Key Trial Info
Start Date :
November 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02255773
Start Date
November 4 2014
End Date
March 27 2024
Last Update
March 29 2024
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030