Cancer Clinical Trial
Official title:
Neuroinflammation in Chronic Systemic Symptoms (CSS): Proof-of-Concept Study Using PET and EEG/ERP Biomarkers
Verified date | January 2023 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the present research protocol is to investigate and identify translocator protein 18kDa, MRI DTI, and EEG/ERPs, markers of Chronic Systemic Symptoms (CSS).
Status | Completed |
Enrollment | 30 |
Est. completion date | December 7, 2021 |
Est. primary completion date | December 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | - Inclusion Criteria for HNC patients: - Age = 21 - HNC of larynx, pharynx, oral cavity paranasal sinus, salivary gland, or unknown primary - Any histology of any epithelial origin - Completed therapy a minimum of 3 months prior to study entry - At least two systemic symptoms on the VHNSS-GSS subscale - Able to speak English to understand instructions and be able to provide informed consent - Exclusion Criteria for HNC patients: - History of neurodegenerative disease, unrelated to cancer history/treatment - Alcohol/substance abuse/dependence within the last 6 months - Current or previous co-morbid bipolar disorder-, psychosis-, obsessive compulsive disorder-, eating disorders-, personality disorders-, - Neurological disorders unrelated to cancer and its treatment (e.g. ADHD, ASDs, epilepsy) - Learning difficulties. - Inclusion Criteria for healthy controls: - Age = 21 - Able to speak English to understand instructions and be able to provide informed consent - Exclusion Criteria for healthy controls: - History of HNC of larynx, pharynx, oral cavity paranasal sinus, salivary gland, or unknown primary - Alcohol/substance abuse/dependence within the last 6 months - Current or previous co-morbid bipolar disorder-, psychosis-, obsessive compulsive disorder-, eating disorders-, personality disorders-, - Neurological disorders (e.g. ADHD, ASDs, epilepsy) - Learning difficulties. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Vanderbilt-Ingram Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Measure: Vanderbilt Head and Neck Symptom Survey (VHNSS) version 2.0 plus general symptom survey (GSS) | Validated tool to measure physical symptom burden and functional deficits related to head/neck cancer and its treatment. | 12 months | |
Other | Clinical Measure: Neurotoxicity Rating Scale (NRS) | 37 item tool examining neurocognitive symptoms associated with neurotoxicity of medical treatment. | 12 months | |
Other | Clinical Measure: Central Sensitivity Inventory (CSI) | Two-part survey consisting of 35 questions. Part A aims to identify frequency of experienced systemic symptoms. Part B determines previous diagnosis of Central Sensitivity Syndromes or related disorders. | 12 months | |
Other | Clinical Measure: Pain Inventory (PI) | Diagram in which patients document specific areas of pain in the body, and rate pain intensity on a scale 1-10 in the past 3 months (i.e. with scores 3+ constituting chronic pain). | 12 months | |
Other | Clinical Measure: Patient Reported Outcomes Measurement Information System (PROMIS-29) | assesses 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, participation in social roles/activities) using 5-point Likert scale, across 29-items. | 12 months | |
Other | Clinical Measure: • Behavior Rating Inventory of Executive Function - Adult version (BRIEF-A) | Measures nine non-overlapping theoretically and empirically derived clinical domains: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and organization of Materials. | 12 months | |
Primary | Positron Emission Tomography (PET) | Centralized Microglial Activation measured via mitochondrial translocator protein 18kDa (TSPO). | 12 months | |
Secondary | EEG/ERP concomitant to working memory neurobehavioral task | Cognitive function as recommended by the International Cognition and Cancer Task Force (ICCTF) | 12 months | |
Secondary | EEG/ERP concomitant to sustained attention neurobehavioral task | Cognitive function as recommended by the International Cognition and Cancer Task Force (ICCTF) | 12 months | |
Secondary | Diffusion Tensor Imaging (DTI) | Diffusion coefficients as measure of cellular inflammation | 12 months | |
Secondary | Peripheral Cytokine and Chemokine Inflammation | Blood marker Interleukin-6 (IL-6) | 12 months | |
Secondary | Peripheral Cytokine and Chemokine Inflammation | Blood marker C reactive protein (CRP) | 12 months | |
Secondary | Peripheral Cytokine and Chemokine Inflammation | Blood marker nuclear factor (NF)-kB transcription factor | 12 months |
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