Clinical trial · Interventional
Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures
NCT02255773CI-TRIAL-00075534completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computerized Tasks | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- High-Fatigue Head and Neck (HNC) Cancer Survivors
- description
- Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.
- interventionNames
- Behavioral: Computerized Tasks
- Behavioral: Questionnaires
- type
- OTHER
- label
- Low-Fatigue Head and Neck (HNC) Cancer Survivors
- description
- Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.