Recruiting

Chemotherapy

Sponsor:

Kessler Foundation

Code:

NCT02896504

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70

Healthy Volunteers: Accepted

Interventions

Exposure: Adjuvant chemotherapy treatment

Exposure: Adjuvant hormonal therapy treatment

Study Details

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

Study ID

NCT02896504

Start date

Sep, 2013

Status verified date

Jan, 2018

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Chemotherapy

Breast Cancer patients undergoing conventional postsurgical adjuvant chemotherapy treatment

Hormonal Therapy

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

Healthy Control

Healthy age, height and body-mass matched healthy controls

Interventions

Exposure: Adjuvant chemotherapy treatment

Exposure: Adjuvant hormonal therapy treatment

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Didier Allexandre, PhD

973324dallexandre@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Didier Allexandre, PhD

973-324-3525dallexandre@kesslerfoundation.org

Principal Investigator:

Guang Yue, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 23, 2018

Last verified

Jan, 2018

Keywords

  • Chemobrain
  • Chemotherapy
  • Hormonal Therapy
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2018-01-23.