Neuroinflammation in Chronic Systemic Symptoms (CSS)

NCT ID: NCT04636723

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-12-07

Brief Summary

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).

Detailed Description

In 2016, there were an estimated 15.5 million cancer survivors in the US, with a forecasted 20.3 million by 2026. Three percent of those survivors were treated for Head and neck cancers (HNC). This number is expected to rise due to increased long-term survival in patients with HPV associated oropharyngeal cancer. Increasing survivorship has generated a surge of interest in late effects of HNC therapy. Studies to date have largely focused on chronic effects stemming from local tissue damage. Recent data suggests that late systemic effects may be equally problematic. Chronic systemic symptoms (CSS) persist far longer than previously considered and are the source of significant function loss and detriment to quality of life. CSS include fatigue, neurocognitive dysfunction, centralized pain, mood disorders, sleep disturbances, and hypothalamic dysfunction manifested as thermal discomfort or hyperhidrosis. Systemic symptoms occur in clusters resulting in a heightened clinical impact. As with other critical illnesses, the trajectory of recovery from the systemic symptoms from cancer treatment is varied. Some patients will recover to baseline quickly post treatment while others display CSS that persist or worsen over time resulting in functional deficits, frailty, and an early aging phenotype which may impact survival. Survivors exhibiting a "slow burn" trajectory as manifested by persistent systemic symptom burden and worsening function over time, require extensive on-going long-term management. These patients often fail to return to work or previously held family roles. CSS may therefore be associated with greater economic cost than the initial treatment.

Work that spans a wide array of inflammatory disease processes (such as fibromyalgia, chronic fatigue syndrome, irritable bowel, etc.) demonstrate the presence of somatic, affective, and cognitive symptoms. Neuroinflammation is hypothesized to be the underlying cause of these symptoms and their manifestations. More specifically, peripheral injury/trauma/cancer release inflammatory mediators that activate glial components of peripheral and central cellular circuitry causing inflammation of the CNS. However, the concept that CSS is underlined by neuroinflammation is largely theoretical from disparate and indirect evidence. A gap in the evidence base suggests direct investigation of neuroinflammation in CSS patients in capturing a mechanistic marker is urgently needed in order to (1) present CSS as a diagnostic entity, (2) fully understand its neurobiological mechanism, and (3) test/develop appropriate treatments.

Conditions

Cancer; Cancer Head Neck; Neuroinflammatory Response; Chronic Inflammation; Chronic Disease; Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HNC Patients w/ CSS

HNC survivor patients presenting high chronic systemic symptoms

No interventions assigned to this group

Healthy Controls

Non-clinical controls

No interventions assigned to this group

HNC Patients wo/ CSS

Patient Control - HNC survivor patients presenting no/low chronic systemic symptoms

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Age ≥ 21
• Able to speak English to understand instructions and be able to provide informed consent

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Poppy Schoenberg

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Poppy Schoenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Osher Center for Integrative Medicine, VANDERBILT UNIVERSITY MEDICAL CENTER

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IRB #202009

Identifier Type: -

Identifier Source: org_study_id