All Drugs and Chemicals

Immunomodulating Agents

Subjects who are currently receiving immunotherapy only.

Subjects who are receiving chemo-immunotherapy.

Subjects who are no currently receiving active therapy.

MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6.

Montreal Cognitive Assessment (MoCA)

Nasser Hanna, MD

The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.

"Chemo brain" has been described as a side effect of conventional chemotherapy and radiotherapy in cancer patients. With the advent of immunotherapy and progress made in treatment of cancer, long term-survival has increased which raises the question of preserving cognitive function in these patients. However, to date, no large center studies have been done to assess the effects of immunotherapy on cognitive function in patients of all cancer types. Studies that have been done are on preclinical models and very small number of patients, which remained inconclusive.

The primary objective of this pilot clinical trial is to estimate the rate of cognitive function change using the MoCA scale over 6 months in each individual group of patients with cancer treated with immunotherapy alone, combined chemotherapy and immunotherapy, and in patients with cancer on no active treatment, respectively. The secondary objective is to estimate the changes of MoCA scores after 3 months and 6 months in patients receiving immunotherapy alone for the treatment of their cancer.

Serial Testing To Assess Cognitive Function In Cancer

Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy

The changes in MoCA scores over 6 months in patients from each group will be plotted and summarized with mean change, standard deviation of change, and standard errors of mean change. The standardized response mean (SRM), calculated as the mean change from baseline to 6 months, divided by the standard deviation of change, will be reported as the main effect size for evaluating the magnitude of change in cognitive function.

Changes of MoCA scores at 3 months and 6 months from the immunotherapy group will be fitted by the mixed-effects linear model including time effects, which will describe the relationship between the common effect of MoCA score changes, the random effect of time, and the random error representing subjects' observation time.

Indiana University

Professor of Medicine, Associate Division Director of Oncology

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Carotid Artery Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago

untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma

IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.

Measurement of intima media thickness of carotid artery

Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound

Detection and measurement of carotid plaques

Velocity measurement of carotid artery to determine carotid stenosis

Carotid Color Flow Duplex Testing

Montreal Cognitive Assessment

Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.

Medical history of cardiovascular risk factors and cardiovascular diseases

Xiaomin Ou, MD

Xiayun He, MD

Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).

The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).

Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT

the intima media thickness of common carotid artery, internal carotid artery of the left or right side

Carotid stenosis is defined as the axial diameter of the carotid lumina decreases more than 50%.

Carotid plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness \>1.5 mm as measured from the media-adventitia interface to the intima- lumen interface.

the higher the number, the better the cognitive function

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Serial Testing To Assess Cognitive Function In Cancer	NCT06160700	Cancer	Montreal Cognit...	18 Years -	Indiana University
Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma	NCT03568032	Nasopharyngeal ... Carotid Artery ...	Measurement of ... Detection and m... Carotid Color F... Montreal Cognit... Medical history...	18 Years -	Fudan University

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