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

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ClinicalTrials.gov Identifier: NCT02896504
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Brief Summary:

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.


Condition or disease Intervention/treatment
Breast Cancer Drug: Exposure: Adjuvant chemotherapy treatment Drug: Exposure: Adjuvant hormonal therapy treatment

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients
Study Start Date : September 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Chemotherapy
Breast Cancer patients undergoing conventional postsurgical adjuvant chemotherapy treatment
Drug: Exposure: Adjuvant chemotherapy treatment
Hormonal Therapy
Breast Cancer patients undergoing conventional postsurgical adjuvant hormonal therapy treatment (with no Chemotherapy)
Drug: Exposure: Adjuvant hormonal therapy treatment
Healthy Control
Healthy age, height and body-mass matched healthy controls



Primary Outcome Measures :
  1. Change in Structural Integrity of the Corpus Collusum as measure by MRI-DTI [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  2. Change in Structural Integrity of the cortico-spinal tract as measure by MRI-DTI [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  3. Change in out-of-phase bimanual finger tapping task performance [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  4. Change in interhemispheric EEG coherence between the left and right motor brain areas [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  5. Change in corticomuscular conduction time using Transcranial Magnetic Stimulation [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  6. Change in response time to a simple reaction time [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients
Criteria

Inclusion Criteria:

  • For all participants

    1. Female aged 20-70
    2. Right handed as determined by the Edinburgh Inventory [40]
    3. Proficient in English
  • For Cancer patients

    1. Had breast cancer surgery
    2. Stage I, II, IIIa
    3. Non metastatic cancer
    4. Chemotherapy Patients: Scheduled to receive or receiving breast cancer chemotherapy with Anthracycline and/or Taxane
    5. Hormonal Therapy Patients: Scheduled to receive or receiving hormonal therapy with Aromatase inhibitor
    6. For patients recruited before adjuvant therapy: Adjuvant therapy starts at least 2 weeks after surgery
    7. For patients recruited after adjuvant therapy started: Before completing/within 1 month post chemotherapy Within 4 months after starting hormonal therapy

Exclusion Criteria:

  1. Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
  2. Significant impairment in ability to understand and analyze information as determined by a Folstein Mini-Mental State Exam score <21.
  3. Prior history of cancer (except breast cancer for breast cancer patients), trauma, neurological, psychiatric, physical or psychological diseases or other conditions that may influence nervous system structure and function
  4. Current medication believed to affect cognitive/psychomotor function (i.e., opioid analgesics, anxiolytics or antidepressants)
  5. History of alcohol, smoking and drug abuse
  6. Transcranial Magnetic Stimulation or MRI contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896504


Contacts
Contact: Didier Allexandre, PhD 973324 dallexandre@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Didier Allexandre, PhD    973-324-3525    dallexandre@kesslerfoundation.org   
Principal Investigator: Guang Yue, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Guang Yue, PhD Kessler Foundation

Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT02896504     History of Changes
Other Study ID Numbers: R-739-12
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kessler Foundation:
Chemobrain
Chemotherapy
Hormonal Therapy
Neuroimaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases