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

NCT02517502 | Completed Early Phase 1 DMC

• 1 other identifier: STUDY00002415
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if a high dose of DHA begun prior to and continued during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent or lessen chemotherapy induced cognitive dysfunction.

Conditions

Cognitive Dysfunction

Keywords

DHA; Omega-3; neoadjuvant chemotherapy; chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (4)

• Trial acceptance

  Number of potentially eligible subjects who consent to participate in the study.

  12 months

• Subject retention and trial completion

  Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.

  Completion of study (~12 months)

• Compliance with taking study agent.

  Number of enrolled subjects who take at least 70% of prescribed study agent.

  Completion of study (~12 months)

• Number of subjects reporting serious adverse events

  Number of enrolled subjects randomized to DHA who report serious adverse events (adjusted for subjects randomized to placebo who report serious adverse events).

  Completion of study (~12 months)

Secondary Outcomes (6)

• Change in Cognitive Ability-General Concerns Questionnaire

  Baseline to Month 12

• Change in Cognitive Ability-Abilities Questionnaire

  Baseline to Month 12

• Change in Quality of Life Questionnaire

  Baseline to Month 12

• Level of Physical Activity Questionnaire

  Month 12

• Change in Cognitive Function test

  Change from Baseline to Month 12

Study Arms (2)

DHA

EXPERIMENTAL

Participants will be asked to take four 400 mg (1600 mg; 1.6 grams) capsules of DHA daily. Participants will start taking capsules before the start of and for the duration of their neoadjuvant chemotherapy.

Drug: DHA

Placebo

PLACEBO COMPARATOR

Participants will be asked to take four 400 mg (1600 mg; 1.6 grams) capsules of a matched placebo daily. Participants will start taking capsules before the start of and for the duration of their neoadjuvant chemotherapy.

Drug: Placebo

Interventions

DHA DRUG

4 capsules of 400 mg DHA daily

Also known as: Docosahexaenoic Acid

DHA

Placebo DRUG

Matched, blinded placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Fabian, MD: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (2)

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Breast Neoplasms

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Carol Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: August 7, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: May 3, 2019
• Last Updated: January 24, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)