Head and Neck Cancer Clinical Trial
Official title:
Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures
Verified date | March 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 27, 2024 |
Est. primary completion date | March 27, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male patients at least 18 years old. 2. Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months. 3. Patients who speak English. 4. Patients who are willing and able to review, understand, and provide written consent. 5. Patients who agree to comply with all study procedures. Exclusion Criteria: 1. Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer. 2. Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator. 3. Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia. 4. 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. 5. Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate. 6. Patients who are enrolled and receiving active treatment in a symptom intervention trial or who are in the treatment phase of a clinical trial. 7. Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the time of screening. 8. Patients who cannot distinguish between the red and blue stimuli of the set-switch task. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue Comparison in Male Head and Neck Cancer Survivors | Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials. | 1 day | |
Secondary | Markers of Inflammation and Fatigue | Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors. | 1 day |
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