Neoplasms

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Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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All Drugs and Chemicals

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Benzocaine

Tannic Acid

In this feasibility study, longitudinal mixed methods will be used to measure cognitive function and symptoms by objective tests, interviews, and biomarker assay in adults with brain cancer over time: prior to radiation (XRT; T1), 2-weeks post-XRT (T2), 2-3 months post-XRT (T3).

Measure cognition function and cognitive reserve in patients before, during and after radiation therapy using cumulative scores of Hollingshead Index, North American Adult Reading Test, HVLT-R, TMT A\&B and COWA over time.

Neuropsychological Testing

Deborah Allen, PhD

Recent research indicates that variability in cognitive function for brain tumor survivors may be explained by differences in cognitive reserve (CR) and use of compensatory strategies.However, it is unknown when cognitive function declines or survivors tap into compensation. This longitudinal mixed methods study proposes to explore differences in cognitive function and change over time in newly diagnosed adults with brain cancer prior to, immediately after (within 2 weeks), and 2-3 months after radiation therapy treatment has been completed.

Specific aims are to:

Aim1: Examine the relationship between objective and subjective cognitive function in subjects newly diagnosed with brain cancer prior to and after XRT.

Aim 2: Explore the interrelationship between cognitive function and compensation (neural and behavioral) by high/low CR prior to and after XRT.

Aim 3: Describe the trajectory of objective and subjective cognitive function over time by CR, cancer type, and associated treatment-related factors.

Cognitive impairments experienced by cancer survivors, from time of diagnosis through the health trajectory, are distressing, persistent, and negatively impact everyday function and quality of life. While reports of cancer- and treatment-related cognitive concerns vary substantially and may be underestimated in some diagnoses, the estimated incidence ranges from 30% in breast cancer up to 90% in brain cancers. Those with brain cancers, including both primary brain tumors and secondary brain metastases, often receive news of their diagnosis during prime productive years of their lives. Due to the cognitive effects from cancer or its treatment, most brain cancer survivors report difficulties returning to work or maintain family demands. Survivors often report co-occurring symptoms or a symptom cluster that include fatigue, sleep and mood disturbances, adding to multimorbidity conditions from the psychoneuroimmunologic effects of cancer. As medical advances have fostered significant gains in cancer survivorship and cancer is now recognized as a chronic illness, there is an urgency to address commonly faced symptoms and chronic conditions throughout the cancer trajectory beginning at time of diagnosis.

Cancer treatment is designed to induce cell death but when treating brain cancers, treatment may negatively impact neurogenesis and neural repair. Previous study indicates that some survivors of brain tumors use behavioral compensation, the investigators aim to understand how neural compensation may be impacted. Cognitive functions associated with biomarkers (NComp) are brain-derived neurotrophic factor (BDNF), catechol-O-methyl transferase (COMT). As survival rises, the investigators need to identify factors that moderate cognitive function in order to develop interventions aimed at minimizing functional decline.

This study is significant as it: 1) describes cognitive variability decline over time, and use of N/BComp; 2) uniquely explores cognition and N/BComp over time; 3) explores moderators of cognitive function across brain cancer survivors, 4) may lead to developing targeted cognitive interventions.

Cognitive function impacts everyday functional abilities and quality of life, however, change in cognition can elude detection. Discrepancies observed between subjective and objective cognitive, co-occurring symptoms, and its relationship with cognitive reserve are new research areas of interest in oncology. Exploring neural or behavioral compensation within the context of cognitive reserve is novel. No known oncology studies have reported the relationship of neural and behavioral compensation with change in cognitive function over time. Examining the trajectory of these variables can aid in identifying potential cognitive interventions for targeted use to prevent decline or maintain function over time.

This study is innovative because it is the first to explore the interface of neural/behavioral compensation and the cognitive trajectory, within a framework of cognitive reserve, in adults newly diagnosed with brain cancers.

Blood samples will be collected for biomarker testing: ELISA ( optional gentyping), BDNF and COMT

Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer

Serial neurocognitive testing using composite scores from the Trail Making A and B test

Serial neurocognitive testing using composite scores from the Controlled Oral Word Association (COWA) test

Serial neurocognitive testing using the composite scores from the Hopkins Verbal Learning Test

Composite scores will be computed using the Functional Assessment of Cancer Cognition Scale

Composite scores will be computed using the Functional Assessment of Cancer-Treatment Cognition Scale

Composite scores will be computed using the Hollingshead Index

Composite scores will be computed using the North American Adult Reading Test

Duke University

Anticoagulants

Nitric Oxide Donors

Edetic Acid

Pentetic Acid

Diethylenetriamine

Patients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).

Patients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).

Whole Brain Irradiation

Partial Brain Irradiation

Quality of Life Questionnaire

MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).

Magnetic Resonance Imaging (MRI) Assessments

Yue Cao, Ph.D.

This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.

MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.

Changes in Magnetic Resonance Imagining (MRI) assessments will be compared graphically to changes in neurocognitive function and clinical symptoms. Parallel analysis will be conducted on each of the neurocognitive tests to determine if MRI assessments can identify patients at increased risk for later neurocognitive dysfunction.

University of Michigan Rogel Cancer Center

Digestive System Diseases

Behaviors and Mental Disorders

Colorectal Neoplasms

Cognitive Dysfunction

Fatigue

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

limited metastatic disease or localised recurrence to receive first line metastatic chemotherapy

neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires

Janette Vardy, MD

Ian Tannock

This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue (the FACT-F), and validated tests of cognitive function, will be applied at predetermined times before, during and after chemotherapy, to determine the incidence, severity and duration of these symptoms. Comparisons will be made in changes in cognition for individuals, as well as between the chemotherapy and the control group. Mechanisms that might lead to fatigue and/or cognitive decline will be investigated.

We will undertake a prospective, longitudinal controlled study of fatigue and cognitive function in 120 patients with localized CRC who receive 5FU-based adjuvant chemotherapy. Each patient will be evaluated at baseline and at 6, 12 and 24 months for fatigue (using the FACT-F questionnaire) and for cognitive function, using validated tests: these will comprise both traditional neuropsychological tests and the computerised CANTAB™, a which is less dependent on fluency in English. Results during and after chemotherapy will be compared with the pre-chemotherapy assessment (so that each patient acts as their own control). Since baseline evaluation may be confounded by the recent diagnosis and surgery we will include an independent control group of 120 patients who have undergone surgery for CRC but who do not receive chemotherapy. Patients found to have cognitive change will be offered further comprehensive neuropsychological assessment. We will also evaluate quality of life (QOL) using the FACT-G questionnaire and anxiety and depression using the General Health Questionnaire (GHQ). Blood tests including hormone levels, cytokines, homocysteine, procoagulants and apo-lipoprotein E-є4 allele status will evaluate possible mechanisms. Finally, since chemotherapy for CRC is evolving to include the more toxic drugs oxaliplatin and irinotecan, we will perform a parallel pilot study evaluating pts with early recurrent or metastatic CRC who receive these drugs, using similar methods of evaluation.

cytokines, genotyping apoE, EUC, LFTs, sex hormones, coagulation factors

Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy

Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer

Canadian Cancer Trials Group

Young Investigator Award - American Society of Clinical Oncologists

Peterborough K.M. Hunter Graduate Studentship

University Health Network, Toronto

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Participants will take neuropsychological testing in-person or via telehealth video

Upon completion of the consent, the subject will be booked into an available 90 minute in-person or remote neuropsychological testing

Neuropsychological testing

Brian J Scott, MD

Michelle Monje, MD, PhD

Gayle Deutsch, PhD, ABPP

Matthew J Frank, MD, PhD

Sheila Lahijani, MD

Tracy P Murray, MSN, RN, AGACNP-BC

Brian Scott, MD

This study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following Axicabtagene ciloleucel CAR-T therapy at Stanford.

Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford

Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford - A Pilot Study

The neuropsychological testing will capture any potential deficits in language, processing speed, executive functioning and visuospatial abilities, and may be compared to age and education-matched normative data.

Items from the SF36 (Short Form 36) survey

Assesses anxiety symptoms

The following cut-offs correlate with level of anxiety severity:

Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety, Score greater than 15: Severe Anxiety

Assesses depressive symptoms PHQ-9 Score 0 - 4 None, Mild= 5 - 9 , Moderate=10 - 14 , Moderately Severe=15 - 19 , Severe=20 - 27

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer	NCT04075370	Primary Brain T... Brain Metastase...	Neuropsychologi...	30 Years - 65 Years	Duke University
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center
Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy	NCT00188331	Cognition Fatigue Colorectal Neop...	Neuropsychologi...	18 Years - 75 Years	University Health Network, Toronto
Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford	NCT05416554	Non Hodgkin Lym...	Neuropsychologi...	18 Years -	Stanford University
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center
Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford	NCT05416554	Non Hodgkin Lym...	Neuropsychologi...	18 Years -	Stanford University
Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer	NCT04075370	Primary Brain T... Brain Metastase...	Neuropsychologi...	30 Years - 65 Years	Duke University

Spots Global Cancer Trial Database for neuropsychological testing