Neoplasms

All Conditions

Behaviors and Mental Disorders

Head and Neck Neoplasms

Quality of Life

Oluwafunmilola T Okuyemi, MD

Jay F Piccirillo, MD, FACS

Cancer survivorship has dramatically improved within the last four decades and a greater number of Americans are living after cancer diagnosis. An increase in the number of survivors has highlighted the need to investigate the quality of life experienced by these survivors. While Survivorship research has improved our understanding of the challenges faced by some cancer survivors, there is a paucity of research on the functional and cognitive health status of head and neck cancer survivors.

The purpose of this study is to evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to increase our understanding of the complex interactions between cancer treatment, comorbid health ailments and quality of life.

Cancer is the second leading cause of death in the United States today, accounting for nearly a quarter of total deaths. Due to advancements in cancer management, specifically in the areas of surveillance, early diagnosis, and utilization of evidenced-based therapies, there has been an increase in the number of survivors in the United States. As at 2007, there were over 11 million cancer survivors in the United States and this number is projected to reach 15 million by the end of 2010. Investigations into the quality of life experienced by these survivors have therefore become necessary if these survivors are to be effectively managed through their course of cancer.

The increase in the number of cancer survivors has opened up a relatively new avenue of cancer research termed Cancer Survivorship Research. Cancer Survivorship Research seeks to investigate the physical, functional and psychosocial consequences of cancer. Despite advances made in survivorship research, gaps remain in our knowledge concerning the ability of the cancer survivor to reintegrate into life and function at pre-cancer levels. These knowledge-gaps are especially true for head and neck cancer patients as demonstrated by the paucity of studies in the literature evaluating the functional and psychosocial consequences of cancer in this cohort. This is a significant short-coming especially since head and neck cancer patients are at increased risks for adverse consequences due to their advanced age at the time of cancer diagnosis, comorbidity burdens and substantial history of alcohol or tobacco use.

This study will evaluate the functional and cognitive changes that occur in head and neck cancer patients as a result of cancer treatment, in an attempt to understand the consequences of cancer treatment on the quality of life experienced by these survivors.

Our study will use self-report questionnaires, neurocognitive assessments and novel performance-based assessments to evaluate functional and cognitive health status at two time-points:

1. At Baseline (before any cancer treatment modality)
2. After the first stage of cancer therapy (chemotherapy, radiation or surgery)

Assessments to be utilized include the Center for Epidemiologic Studies Depression Scale (CES-D), University of Alabama Life Space Assessment Aids form (LSA Aids), Dysexecutive Questionnaire (DEX), Katz Index of Activities of Daily Living (ADLs), Lawton Index of Instrumental Activities of Daily Living (IADLs), University of Alabama Life Space Assessment (LSA), Short Blessed Test (SBT), Short Physical Performance Battery (SPPB), Adult Comorbidity Evaluation-27 (ACE-27), and the Delis Kaplan Executive Function Scale (DKEFS) - Sorting task, Color Word Interference task, and Trail Making task.

Participants will also be assessed using the Executive Function Performance Test (EFPT). The EFPT is a performance-based measure of cognitive function developed at the Program for Occupational Therapy at Washington University School of Medicine that assesses (under direct observation) the amount of assistance needed by participants to complete five basic tasks essential for self-maintenance and independent living. The tasks include hand-washing, cooking, using the telephone, taking medications and paying bills.

Head and Neck cancer patients will undergo these comprehensive assessments at each of the two time-points, allowing for the ability to follow changes in function and cognition over the course of cancer therapy. Statistical analyses will be performed with the SAS® software version 9.1.3 to obtain descriptive statistics and to investigate statistically-significant changes in functional and cognitive health status between the time-points evaluated.

Comprehensive Assessment of Head and Neck Cancer Survivors

A Comprehensive Assessment of Adult Head and Neck Cancer Survivors (A Pilot Study)

University of Alabama at Birmingham

Jay F. Piccirillo, MD

Professor, Washington University School of Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Substance Related Disorders

Rare Diseases

Cognitive Dysfunction

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Chemotherapy-Related Cognitive Impairment

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Taxane

All participants receive pre- and post-chemotherapy neurocognitive assessments. A sequentially-assigned subset also receive pre- and post-chemotherapy Functional Magnetic Resonance Imaging (FMRI) procedures.

Baseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI)

Neurocognitive assessments

Rachel W Miller, MD

Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.

Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain. In order to address these important objectives, a diverse team of experienced investigators has been assembled to design and implement the proposed protocol. The research team for this project seeks to accomplish the proposed objectives through following mechanisms: 1) assessment of the neurocognitive domains affected in CICI using a tailored battery of cognitive tests to define CICI; 2) measurement of serum markers of oxidative stress and correlation of these markers with neurocognitive test results; and 3) exploration of structural and functional changes in the brain during cognitive tasks and correlation of results with markers of oxidative stress and neurocognitive test results.

Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients

Chemotherapy-Induced Cognitive Impairment in Patients With Ovarian Cancer: A Phase II Study of the Cognitive Effects of Platinum/Taxane-based Chemotherapy in Patients With Ovarian Cancer

To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.

Analysis of covariance (ANCOVA), adjusting for baseline log serum levels, will be utilized to assess for differences in log levels over timepoints including the 4 and 6 hour samples. Spearman correlations will be utilized to describe associations with cognitive tests scores and biochemical measured in addition to Spearman Correlation coefficients between baseline biochemical measures.

For neurological outcomes, a longitudinal comparison before and after Chemotherapy in fMRI (percent signal change and extend of activation voxels), DTI (FA % change), and ERP (uV) will be performed. There will be changes in patterns of fMRI responses, FA, and ERP signals from baseline to after treatment. We expect that fMRI activation will be change in prefrontal regions change of effort needed to do the memory task. Changes in white matter FA in after the treatment may be observable in the white matter regions such as the frontal and temporal cortices as well as in gray matter regions suspected to be affected by the Chemo. Cognitive ERP patterns will be changed in the same individuals. fMRI and ERP analysis can be analyzed and compared at individual level.

To explore correlations between fMRI outcomes and cognitive measures, ANCOVA is an appropriate choice since we want to study measures after treatment, relative to initial values.

Office of US Army Medical Research and Material Command

Rachel Miller

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Assessment of Head and Neck Cancer Survivors	NCT01222481	Head and Neck C...		40 Years -	Washington University School of Medicine
Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients	NCT03324945	Chemotherapy-in...	Neurocognitive ...	18 Years -	University of Kentucky
Comprehensive Assessment of Head and Neck Cancer Survivors	NCT01222481	Head and Neck C...		40 Years -	Washington University School of Medicine
Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients	NCT03324945	Chemotherapy-in...	Neurocognitive ...	18 Years -	University of Kentucky

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