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

January 18, 2018 updated by: Kessler Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Recruiting
        • Kessler Foundation
        • Contact:
        • Principal Investigator:
          • Guang Yue, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Guang Yue, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-739-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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