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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Kessler Foundation
Sponsor:
Collaborator:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT02896504
First received: September 6, 2016
Last updated: October 13, 2016
Last verified: October 2016
  Purpose

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 Intervention
Breast Cancer
Drug: Exposure: Adjuvant chemotherapy treatment
Drug: Exposure: Adjuvant hormonal therapy treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Change in corticomuscular conduction time using Transcranial Magnetic Stimulation [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]
  • Change in response time to a simple reaction time [ Time Frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control) ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Guang Yue, PhD Kessler Foundation
  More Information

Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT02896504     History of Changes
Other Study ID Numbers: R-739-12
Study First Received: September 6, 2016
Last Updated: October 13, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on March 23, 2017