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

NCT02896504 | Unknown

• 1 other identifier: R-739-12
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Chemobrain; Chemotherapy; Hormonal Therapy; Neuroimaging

Outcome Measures

Primary Outcomes (6)

• Change in Structural Integrity of the Corpus Collusum as measure by MRI-DTI

  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

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

• Change in out-of-phase bimanual finger tapping task performance

  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

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

• Change in corticomuscular conduction time using Transcranial Magnetic Stimulation

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

• Change in response time to a simple reaction time

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

Study Arms (3)

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

Interventions

Exposure: Adjuvant chemotherapy treatment DRUG

Chemotherapy

Exposure: Adjuvant hormonal therapy treatment DRUG

Hormonal Therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients

You may qualify if:

• For all participants
• Female aged 20-70
• Right handed as determined by the Edinburgh Inventory \[40\]
• Proficient in English
• For Cancer patients
• Had breast cancer surgery
• Stage I, II, IIIa
• Non metastatic cancer
• Chemotherapy Patients: Scheduled to receive or receiving breast cancer chemotherapy with Anthracycline and/or Taxane
• Hormonal Therapy Patients: Scheduled to receive or receiving hormonal therapy with Aromatase inhibitor
• For patients recruited before adjuvant therapy: Adjuvant therapy starts at least 2 weeks after surgery
• For patients recruited after adjuvant therapy started: Before completing/within 1 month post chemotherapy Within 4 months after starting hormonal therapy

You may not qualify if:

• Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score \>14
• Significant impairment in ability to understand and analyze information as determined by a Folstein Mini-Mental State Exam score \<21.
• 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
• Current medication believed to affect cognitive/psychomotor function (i.e., opioid analgesics, anxiolytics or antidepressants)
• History of alcohol, smoking and drug abuse
• Transcranial Magnetic Stimulation or MRI contraindication

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Guang Yue, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier Allexandre, PhD

CONTACT

973324; dallexandre@kesslerfoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)