Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Breast Neoplasms

Chemotherapy-Related Cognitive Impairment

Breast Diseases

Skin Diseases

Breast Cancer patients undergoing conventional postsurgical adjuvant chemotherapy treatment

Breast Cancer patients undergoing conventional postsurgical adjuvant hormonal therapy treatment (with no Chemotherapy)

Healthy age, height and body-mass matched healthy controls

Exposure: Adjuvant chemotherapy treatment

Exposure: Adjuvant hormonal therapy treatment

Didier Allexandre, PhD

Guang Yue, PhD

Some cancer patients report experiencing mild problems with thinking during or following chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and difficulty performing complex or multi-tasks. These symptoms often soon disappear after treatment. However for some patients, they may persist for years and this can have a significant effect on their quality of life. The reasons for these symptoms are not well understood.

This study proposes to examine the effects of chemotherapy on the brain and how the changes in the brain affect one's ability to move one's arms and fingers. By better understanding the negative consequences of chemotherapy on the brain and nervous system, the hope is to help pharmaceutical companies develop safer cancer treatment drugs.

Adjuvant chemotherapy (CTh) is an established postoperative treatment often prescribed to cancer patients to reduce risk of relapse. However, a great proportion of patients report experiencing cognitive, psychomotor, and other functional impairments associated with CTh. Some symptoms may persist for years after treatment and can have dramatic consequences on cancer survivors' quality of life. Despite numerous studies reporting various symptoms during/after CTh treatment, mechanisms underlying these symptoms are not well understood. Recent animal and human brain imaging studies suggest that CTh may have direct neurotoxic effects on the brain, in particular on brain white matter (WM). However, to date, no longitudinal studies have been done to examine the effects of CTh on cortical/subcortical WM integrity in human patients. Furthermore, no effort has yet been made to correlate a given WM structure with its corresponding neurophysiological function (NPF) and behavior. This study proposes longitudinal experiments in women diagnosed with breast cancer to examine the effects of CTh on the corpus callosum (CC) and corticospinal tract (CST) (Aim 1), on NPF that directly depends on the quality of CC/CST structure, and on psychomotor behavior critically relying on CC/CST function (conductivity) (Aim 2). The relationship between CC/CST structural integrity and their corresponding NPF and psychomotor behavior will also be examined (Aim 3). The general underlying hypotheses of the study are that (1) CTh has a direct neurotoxic effect on the CC and CST, resulting in microstructural degeneration and (2) structural damage to the CC and CST impairs relevant neurophysiological function and behavior. This research is expected to yield significant information regarding neural structural and physiological causes of CTh-related side effects; known this information would help more effectively manage the symptoms. By demonstrating direct evidence of detrimental consequences of CTh on the central nervous system, it is hoped that the evidence would encourage pharmaceutical companies to develop safer cancer treatment drugs.

Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients

Kessler Foundation

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Obesity

Body Weight

Weight Loss

Uterine Neoplasms

Endometrial Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.

Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.

Exercise on stationary recumbent exercise cycle

Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)

Health Education

Questionnaires

Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.

Neuroimaging

Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).

Genetic and Biomarkers

Nora Nock, PhD

This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.

Primary Objective:

To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-EOT, in obese EC patients who will be randomized to perform 'assisted' or voluntary exercise.

Secondary Objectives:

Objective 1: To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go signaling (SST) in fed states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-intervention in obese EC patients performing 'assisted' and voluntary exercise.

Objective 2: To examine the modification of the neuronal response to high vs. low calorie food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating homeostatic and non-homeostatic energy systems.

Patients will be randomized to receive either the assisted exercise (n=60) or voluntary exercise (n=60) group. Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks. The control group will be asked to complete all exercise, body composition and fMRI testing similar to the exercise groups.

Assisted Exercise in Obese Endometrial Cancer Patients

REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients

Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: \< 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight)

Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire.

Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger.

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures.

The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms).

Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program.

Case Comprehensive Cancer Center

Nervous System Diseases

Gland and Hormone Related Diseases

Eye Diseases

Adenoma

Pituitary Diseases

Vision, Low

Pituitary Neoplasms

Vision Disorders

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Sensation Disorders

Neurologic Manifestations

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients with visual impairment caused by chiasma compression from sellar area tumors will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.

Volunteers with no visual impairment(visual acuity of both eyes \>1.0) or Nervous System disease will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.

resting state fMRI

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

visual tasking state fMRI

Define the integrity of white matter fibers in the visual pathway.

diffusion tensor imaging

Identify the existence and type of visual field defect.

automated visual field

Assess the visual acuity by using ETDRS scales.

visual acuity

Liu Z Xiong, MD/PhD

Zhong W Ming, MD

Sellar area tumors such as pituitary adenoma, craniopharyngioma and meningioma, etc, commonly lead to visual impairment symptoms. Patients suffer from a loss of visual acuity (VA) and visual field defects (VF) due to a local compression on the optic chiasma by the tumor. In the management of these patients, it is an important goal to evaluate their visual function throughout the treatment, so as to predict the outcome of the visual function .

Since the visual pathway contains a huge complex network of both structure and function, traditional simplex evaluation of VA and VF is obviously not enough. Former studies have revealed changes in the visual network and cortex structure in neurodegenerative diseases and optic neuritis, yet the functional and structural changes caused by local tumor compression and their relation to the visual cortex activity patterns needs further research.

The objective of this research is to asses the visual function in patients with sellar area tumor 1 week preoperatively (baseline),72 hours postoperatively(checking point 1) and at 3 months follow up(checkpoint 2). By using multimodal evaluation including visual resting and task state fMRI, diffusion tensor imaging (DTI), etc. The investigators aim to reveal the changes in functional connectivity (FC), amplitude of low frequency fluctuation (ALFF), regional homogeneity (REHO) ,visual cortex activity patterns and tract-based spatial statistics (TBSS).

Detailed Description:

Study objective

Visual pathway contains both structural and functional network. When it is impacted by neurodegenerative diseases, neuritis or direct mechanical pressure, visual impairment occurs due to damage to the pathway. Former study on Parkinson's disease (Dagmar H. Heep et al, Radiology, 2017 ) found loss of functional connectivity in posterior and paracentral brain regions, while a study on optic neuritis (Yael Backner et al, JAMA Neurology,2018) showed an increase in functional connectivity and slightly loss in optic fiber integrity. Instead of simplex resting-state fMRI，the investigators of this study aim to assess:

1. whether similar changes in functional networking occur when visual pathway is impacted by chiasma compression from tumors in sellar area (by resting-state fMRI).
2. The correlation between local chiasma compression and visual cortex activation pattern ( by visual tasking-state fMRI).
3. Changes and recovery of the white matter fiber structure in the visual pathway.

( by diffusion tensor imaging, DTI).

Method Participants: 60 adult participants (18-60 years old ) will be enrolled in the department of Neurosurgery at Xiangya Hospital of Central South University. The experimental arm will consist of 30 patients with visual impairment symptoms caused by chiasma compression by sellar area tumors (Tumor Group, TG). The control arm will consist of 30 healthy controls without any nervous system disease or visual impairment (Healthy Control Group, HC, control arm).

Study design: Transversal and Longitudinal, single center, comparative study is designed to evaluate functional and structural visual networking of sellar area tumor patients and healthy controls. The study involves assessment with resting-state fMRI, tasking-state fMRI and DTI. Patients of experimental arm will be evaluated by multimodal fMRI at 3 different checkpoints (baseline is 1 week preoperative ,checkpoint 1 is 72 hours postoperative ,checkpoint 2 is 3 months follow up ). Participants of control arm will be evaluated only once. Transversal comparison will be conducted between preoperative tumor patients and healthy controls, while longitudinal comparison will be within tumor group at baseline and two other different checkpoints.

MRI data acquisition and analysis strategy: In this study, the MRI data is acquired by Siemens 3.0T Prisma scanner, including sequences of mprage T1 , diffusion tensor imaging, resting-state fMRI and visual stimulation task fMRI. Resting-state fMRI longitudinal data analysis includes functional connectivity (FC), amplitude of low frequency fluctuation (ALFF) and regional homogeneity (REHO) to assess visual functional networking in both group. These Data wil be analysed using a multivariate approach and independent component analysis (ICA). Visual tasking fMRI will be conducted under classic black and white "chess board" simulation on each eye. For the evaluation of structural visual network, afferent visual pathway (optic tract and radiation ), fiber tracking as well as tract-based spatial statistics (TBSS) will be analyzed within both arms at baseline,checkpoint 1 and checkpoint 2 of the experimental arm will verify changing and recovering process of the visual pathway after chiasma decompression.

Primary outcomes

1. The difference in visual pathway anatomy and functional network between preoperative sellar area tumor patients and healthy controls. Tumor patients will be evaluated clinically by visual acuity (VA), visual field (VF), tumor height and chiasma thickness.
2. The verification of the correlation between patterns of chiasma compression and visual cortex activity. Revealing the difference of visual cortex activity patterns between both arms.

Secondary outcomes Throughout the 3 months follow up of the experimental arm patients, observe and verify the recovery process of both functional and structural visual network after chiasma decompression and evaluate its correlation with clinical visual function outcome.

Statistics

1. An analysis of two sample T test between the two groups will be performed to assess the difference of FC,REHO,ALFF and visual cortex activity pattern between resting state data and data from the visual task of TG and HC.
2. An analysis of variance (ANOVA) within TG group will be performed to assess the changes and recovery of FC, REHO, ALFF and visual cortex activity pattern via resting state data and data from the visual task's data.

Correlations will be explored between multimodal fMRI parameters (both functional and structural) and clinical criteria (e.g VA,VF, tumor size, visual outcome, etc).

Clinical Study of Structural and Functional Evaluation of the Visual Pathway

Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors

Outcomes of visual resting state fMRI to assess the functional connectivity (FC) of visual resting network.

Outcomes of visual BOLD fMRI to assess the function of visual cortex by measuring the signal strength (T-test score) of the visual cortex activation.

Outcomes of tract-based spatial statistics (TBSS) to assess the integrity of the white matter fibers in the posterior visual pathway.

Outcomes of visual acuity test for evaluation of the visual function impairment and recovery.

Visual Field Defects via Humphrey visual field chart, Mean Deviation and Standard Deviation in the patients' group at different checkpoints.

Visual resting state fMRI data will be analysed to assess the ALFF data of visual resting network

Outcomes of visual resting state fMRI to assess the regional homogeneity (REHO) of visual resting network.

Outcomes of fractional atrophy (FA) on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.

Outcomes of axial diffusivity (AD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.

Outcomes of radial diffusivity (RD) value on the posterior visual pathway via diffusion tensor imaging (DTI) and fiber tractography.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients	NCT02896504	Breast Cancer	Exposure: Adjuv... Exposure: Adjuv...	20 Years - 70 Years	Kessler Foundation
Assisted Exercise in Obese Endometrial Cancer Patients	NCT01870947	Stage I Endomet... Uterine Cancer Obesity	Exercise on sta... Health Educatio... Questionnaires Neuroimaging Genetic and Bio...	18 Years -	Case Comprehensive Cancer Center
Clinical Study of Structural and Functional Evaluation of the Visual Pathway	NCT03591315	Pituitary Adeno... Visual Impairme... Sellar Tumor Neuroimaging	resting state f... visual tasking ... diffusion tenso... automated visua... visual acuity	18 Years - 60 Years	Xiangya Hospital of Central South University
Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients	NCT02896504	Breast Cancer	Exposure: Adjuv... Exposure: Adjuv...	20 Years - 70 Years	Kessler Foundation

Spots Global Cancer Trial Database for neuroimaging

Every month we try and update this database with for neuroimaging 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.