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

Primary Purpose

Cognitive Dysfunction

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
DHA
Placebo
Sponsored by
Carol Fabian, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Dysfunction focused on measuring DHA, Omega-3, neoadjuvant chemotherapy, chemotherapy, breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Decatur Memorial Hospital
  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHA

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Trial acceptance
Number of potentially eligible subjects who consent to participate in the study.
Subject retention and trial completion
Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.
Compliance with taking study agent.
Number of enrolled subjects who take at least 70% of prescribed study agent.
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).

Secondary Outcome Measures

Change in Cognitive Ability-General Concerns Questionnaire
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-General Concerns). There are a total of 34 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Change in Cognitive Ability-Abilities Questionnaire
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-Abilities). There are a total of 33 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Change in Quality of Life Questionnaire
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS 29-Profile). The PROMIS 29-Profile includes 4 items from 7 different domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities, along with a single item on pain intensity). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Level of Physical Activity Questionnaire
Physical activity will be tracked over course of the study. Participants will complete a physical activity questionnaire (PAQ-4) at each visit.
Change in Cognitive Function test
Change measured based on standard battery of cognitive tests including Hopkins Verbal Learning Test-Revised, Trail Making A, Trail Making B and Controlled Oral Word Association.
Measurement of Cognitive Function Mobile Cognitive Assessment Battery (MCAB) Questionnaire
The MCAB measures working memory, divided attention/multitasking, cognitive flexibility and processing speed and also includes a 33 item self-rating questionnaire that assesses everyday cognitive behaviors, physical activity, sleep, pain and functional adjustment.

Full Information

First Posted
July 8, 2015
Last Updated
January 6, 2022
Sponsor
Carol Fabian, MD
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02517502
Brief Title
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
Official Title
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carol Fabian, MD
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 preventative treatment against development of cognitive problems which can arise in some individuals during chemotherapy treatment. In doses of 1-2 grams per day it has been found to improve some aspects of cognitive function in healthy adults who have low DHA dietary intake. It has also been shown to improve some aspects of function in individuals with a mild reduction in cognitive ability but not for those with marked impairment. Participation in this study will last about 12 months. Participants will make visits to the study site for both standard of care visits and additional study-related visits. Participants will be randomized (randomly assigned; like flipping a coin) to one of two groups. Neither the Investigator nor the participant will know the assigned treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
DHA, Omega-3, neoadjuvant chemotherapy, chemotherapy, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DHA
Other Intervention Name(s)
Docosahexaenoic Acid
Intervention Description
4 capsules of 400 mg DHA daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched, blinded placebo
Primary Outcome Measure Information:
Title
Trial acceptance
Description
Number of potentially eligible subjects who consent to participate in the study.
Time Frame
12 months
Title
Subject retention and trial completion
Description
Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.
Time Frame
Completion of study (~12 months)
Title
Compliance with taking study agent.
Description
Number of enrolled subjects who take at least 70% of prescribed study agent.
Time Frame
Completion of study (~12 months)
Title
Number of subjects reporting serious adverse events
Description
Number of enrolled subjects randomized to DHA who report serious adverse events (adjusted for subjects randomized to placebo who report serious adverse events).
Time Frame
Completion of study (~12 months)
Secondary Outcome Measure Information:
Title
Change in Cognitive Ability-General Concerns Questionnaire
Description
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-General Concerns). There are a total of 34 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Time Frame
Baseline to Month 12
Title
Change in Cognitive Ability-Abilities Questionnaire
Description
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS-Abilities). There are a total of 33 questions. Each question has five response options ranging in value from one to five (never to very often). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Time Frame
Baseline to Month 12
Title
Change in Quality of Life Questionnaire
Description
Change measured using Patient-Reported Outcomes Measurement Information System (PROMIS 29-Profile). The PROMIS 29-Profile includes 4 items from 7 different domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities, along with a single item on pain intensity). The total score is based on the sum of the responses, multiplied by the number of questions and then divided by the number of questions that were answered.
Time Frame
Baseline to Month 12
Title
Level of Physical Activity Questionnaire
Description
Physical activity will be tracked over course of the study. Participants will complete a physical activity questionnaire (PAQ-4) at each visit.
Time Frame
Month 12
Title
Change in Cognitive Function test
Description
Change measured based on standard battery of cognitive tests including Hopkins Verbal Learning Test-Revised, Trail Making A, Trail Making B and Controlled Oral Word Association.
Time Frame
Change from Baseline to Month 12
Title
Measurement of Cognitive Function Mobile Cognitive Assessment Battery (MCAB) Questionnaire
Description
The MCAB measures working memory, divided attention/multitasking, cognitive flexibility and processing speed and also includes a 33 item self-rating questionnaire that assesses everyday cognitive behaviors, physical activity, sleep, pain and functional adjustment.
Time Frame
Change from Baseline to Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Fabian, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Global results will be published.

Learn more about this trial

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

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