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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kessler Foundation
• Collaborator: Rutgers Cancer Institute of New Jersey

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