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Search / Trial NCT02517502

Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy

Launched by CAROL FABIAN, MD · Aug 4, 2015

Trial Information

Current as of April 28, 2025

Completed

Keywords

Dha Omega 3 Neoadjuvant Chemotherapy Chemotherapy Breast Cancer

ClinConnect Summary

Chemotherapy is often associated with problems of cognitive functioning such as decision making, learning, and memory. These symptoms, collectively referred to here as cognitive dysfunction can appear as early as the first few months after starting chemotherapy and may persist long after chemotherapy and anti-hormone therapy, if any, is completed.

Once developed there is no satisfactory treatment for cognitive dysfunction although cognitive retraining and exercise may improve symptoms and/or function; at least for some.

Omega-3 fatty acids derived from ocean fish are a new potential preve...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of invasive breast cancer (Stage I-III) and are anticipated to start neo-adjuvant chemotherapy (multiple chemotherapy regimens allowed under protocol)
  • Able to read, write, and understand English and at least have a high school education.
  • Able and willing to go at least 24-36 hours without narcotic pain medicine, muscle relaxants, sedatives, sleeping pills and alcohol prior to their cognitive testing. Participants should not have required chronic sedatives, sleeping aids, or narcotic pain medications on a daily basis prior to their diagnosis.
  • Willing to complete required study procedures from start of study to approximately 6 months after completion of neo-adjuvant chemotherapy.
  • Exclusion Criteria:
  • Women who are currently on omega-3 fatty acid supplements with \> 500 mg of EPA plus DHA daily or 250 mg of DHA alone and or who have chronically been on more than 1 fish oil capsule per day.
  • Individuals who are not willing to stop fish or krill oil supplements during the study.
  • Diabetics requiring insulin treatment.
  • Individuals who are not likely to be able to go for 24 hours without sleeping pills, sedatives, narcotic pain medications, or ativan
  • Individuals who do not have a high school education or are not fluent in English.
  • Individuals who have already started chemotherapy for breast cancer or who have previously had systemic chemotherapy for a malignancy.
  • Women who have already had definitive surgery for breast cancer.

About Carol Fabian, Md

Dr. Carol Fabian, MD, is a distinguished clinical trial sponsor known for her extensive expertise in oncology and women's health. With a robust background in clinical research and a commitment to advancing cancer treatments, Dr. Fabian leads innovative trials aimed at improving patient outcomes and enhancing therapeutic options. Her collaborative approach, combined with a deep understanding of the complexities of cancer care, positions her as a trusted leader in the medical research community. Through her efforts, Dr. Fabian strives to bridge the gap between scientific discovery and practical application, ultimately contributing to the development of effective, evidence-based treatments for patients.

Locations

Kansas City, Kansas, United States

Decatur, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Carol Fabian, MD

Principal Investigator

University of Kansas Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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