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

Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Nervous System Diseases

Fatigue

Chemotherapy-Related Cognitive Impairment

Amnesia

Central Nervous System Stimulants

Cardiotonic Agents

Dexmethylphenidate Hydrochloride

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

dexmethylphenidate(d-mph)

To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.

D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of d-MPH in the Treatment of Fatigue and Neurobehavioral Impairment Related to Chemotherapy in Adult Cancer Patients

Celgene Corporation

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Nicotine

Nicotinic Agonists

Cholinergic Agents

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Placebo Transdermal Patch

Paul A Newhouse, M.D.

The purpose of this study is to evaluate the use of a nicotine patch as a treatment for problems with attention, learning and memory in breast cancer patients who are 1-5 years post chemotherapy.

Studies have suggested that chemotherapy treatment for breast cancer may change the way the brain functions. As a result, patients who receive chemotherapy for breast cancer may experience problems with their attention, learning, and memory that they did not have before receiving chemotherapy. The investigators have found that nicotine treatment can help other types of patients with similar difficulties with attention, learning, and memory. Nicotine is a naturally occurring substance found in tobacco and is known to interact with nerve cells in the brain that are important for functions like learning and memory, and has been studied in a number of disorders. This study is designed to test whether nicotine treatment is helpful for learning and memory problems after chemotherapy for breast cancer.

This study will be a randomized, placebo-controlled pilot study to evaluate the effect of transdermal nicotine to 1) reduce subjective complaints and 2) enhance cognitive performance on laboratory measures of cognitive performance in breast cancer patients with persistent chemotherapy-related cognitive impairment (CRCI), a condition also known as "chemo brain." Participants will be randomized to either placebo or active compound (50/50) for the 6-week treatment portion of the study. Participants will be assessed before, during, and at the end of treatment. At the end of the 8-week study, participants will have the option to take part in the open-label portion of the study for an additional 6 weeks.

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale will be used to monitor change in CRCI subjective complaints.

This instrument has been used to monitor change in CRCI subjective complaints in previous studies and demonstrates good internal consistency, test-retest reliability, and discriminant and convergent validity. Specifically, the PCI subscale was used as the primary outcome measure.

The FACT-Cog PCI consists of 20 items and has a minimum score of 0 and total possible score of 72. Higher scores indicate better cognitive functioning.

The PCI evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability.

Visit 3 is the 3-week visit, Visit 4 is the 6-week visit, and Visit 5 is the 8-week visit.

Change scores were calculated as follow

The secondary outcome measure was the computerized Conners Continuous Performance Test (CPT), which measures sustained attention and vigilance. Participants see a series of letters appearing one at a time on a computer screen and they press a button for every letter that appears on the screen, except for "X". Lower scores indicate better performance.

Scores on the CPT are calculated using the each participant's performance on the task (defined as reaction time (in ms) standard error/interstimulus interval). Change scores from baseline are then calculated. A decrease in CPT score = improvement.

\*This is not a clinical measure. This is a research measure of reaction time variability and therefore there is no clinical interpretation and no defined score range.\*

Vanderbilt University Medical Center

Professor of Psychiatry, Pharmacology, and Medicine

Adverse events were recorded and categorized by body system, event type, attribution, frequency, severity, and course. AEs were assessed across all double-blind study visits and categorized according to body system for all participants who received at least one dose of patches (nicotine n = 12, placebo n = 13).

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal Nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Cancer Type

Cancer Stage

Chemotherapy

Surgery

Radiation

Cancer Treatment Received

Current Endocrine Therapy

Post-Menopausal Status

Small sample size numbers; treatment duration of 6-weeks may not have been enough time to distinguish between a drug and placebo response; 14mg may not have been a sufficient dose to fully test this hypothesis.

Dr. Paul A. Newhouse

For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 PCI Change from Baseline Score (3-Weeks)

Visit 4 PCI Change from Baseline Score (6-Weeks)

Visit 5 PCI Change from Baseline Score (8-Weeks)

Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale

For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 CPT Change from Baseline Score (3-Weeks)

Visit 4 CPT Change from Baseline Score (6-Weeks)

Visit 5 CPT Change from Baseline Score (8-Weeks)

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch: Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Conners Continuous Performance Test

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Joseph McCollom, DO

Emily Powell, PHD

Dr Joseph McCollom, DO

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

All self representation of gender identity accepted

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.

Indiana University School of Medicine

Joseph McCollom

Oncologist

Neurobehavioral Manifestations

Neurologic Manifestations

Without self-report cognitive impairment.

Jay F. Piccirillo, MD

The investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these structural and functional changes are responsible for the cognitive symptoms associated with chemotherapy-induced cognitive impairment (CICI).

The Specific Aim for this study is:

To assess the impact of chemotherapy on structural white matter as defined by DTI and functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer survivors with self-reported CICI to breast cancer survivors without CICI.

Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have abnormal structural connections characterized by DTI-defined disruptions in fractional anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without self-reported CICI.

Chemotherapy has been linked to cognitive impairments among breast cancer patients, especially in the domains of executive function (planning and problem solving), attention, learning, and information processing. The etiology of these chemotherapy-associated impairments remains unknown, although recent neuroimaging studies suggest that disruption of white matter integrity may play a role. With continued use of chemotherapy in breast cancer patients, this study's novel use of functional neuroimaging will be significant to better inform practitioners and patients of potential consequences to anticipate and serve as a starting point in the development of therapeutic interventions.

Chemotherapy-Induced Cognitive Impairment

The Neurobiology of Chemotherapy-Induced Cognitive Impairment

As compared with the controls, the breast cancer patients will show decreased fractional anisotropy (FA) in the frontal and temporal white matter (WM) tracts and.

As compared with the controls, the breast cancer patients will show decreased functional integrity of the default mode network \[DMN\], associated with memory; the dorsal and ventral attention networks \[DAN/VAN\], involved in attention; and the Cognitive/Control network, involved in executive decision-making

As compared with the controls, the breast cancer patients will show increased mean diffusivity (MD) in frontal White Matter (WM).

Washington University Siteman Cancer Center

Barnes-Jewish Hospital

Professor

Breast Diseases

Skin Diseases

Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy.

Jason Parker, PhD

We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.

In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.

Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy

Kettering Health Network

Carcinoma

Carcinoma, Ductal

Hormones

any stage of breast cancer without brain metastasis, will undergo hormonal therapy without chemotherapy

any stage of breast cancer without brain metastasis, will undergo chemotherapy and hormonal therapy

any stage of breast cancer without brain metastasis, has undergone surgery prior to screening, will undergo chemotherapy without hormonal therapy

any stage of breast cancer without brain metastasis, will not undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no therapy

Lei Wang, PhD

The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.

This study aims to identify neuroimaging biomarkers for predicting mild cognitive impairment (MCI) in breast cancer patients receiving adjuvant chemo and/or hormonal therapy by examining hippocampal-cortical neurocircuitry. Adjuvant therapies increase long-term survival, but produce changes in cognitive function in 30% (up to 70%) of women on average with breast cancer. Cognitive decline negatively impacts quality of life in patients and their supporters. Therefore, early identification of patients at risk for developing treatment-related cognitive impairment is needed to develop potential prevention or treatment options and prevent further decline. Our recent work demonstrates that patients receiving adjuvant hormonal treatment exhibit decline in cognition as soon as three months post treatment. Although neuroimaging studies have identified brain changes associated with chemotherapy ("chemo brain", no investigation has assessed the type and severity of such changes following hormonal therapy, nor has any study determined which individuals are at greatest risk for cognitive impairment.

Our central hypothesis is that measures of the hippocampal-cortical integrity can be used to predict cognitive decline, and changes of specific domains of cognitive performance in patients receiving adjuvant therapy over time will be related to changes in specific components of this circuitry over time.

Mild Cognitive Impairment in Breast Cancer Patients

Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

Measured using a neuropsychological test battery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Serial Testing To Assess Cognitive Function In Cancer	NCT06160700	Cancer	Montreal Cognit...	18 Years -	Indiana University
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients	NCT00047476	Fatigue Neoplasms	dexmethylphenid...	18 Years - 70 Years	Celgene
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health
Chemotherapy-Induced Cognitive Impairment	NCT01578083	Cognitive Sympt...		35 Years - 70 Years	Washington University School of Medicine
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy	NCT01045044	Breast Cancer		18 Years - 65 Years	Kettering Health Network
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy	NCT01045044	Breast Cancer		18 Years - 65 Years	Kettering Health Network
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy	NCT01045044	Breast Cancer		18 Years - 65 Years	Kettering Health Network
Mild Cognitive Impairment in Breast Cancer Patients	NCT01949376	Breast Cancer Cognitive Impai...		40 Years - 70 Years	Northwestern University
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health

Spots Global Cancer Trial Database for chemo brain

Every month we try and update this database with for chemo brain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chemo brain

Every month we try and update this database with for chemo brain cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chemo brain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.