Cognitive DysfunctionEarly Phase 1NCT02517502
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
A Early Phase 1 study testing DHA in people with Cognitive Dysfunction, run by Carol Fabian, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to 3 May 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Decatur Memorial Hospital
Decatur, Illinois, 62526
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- DHA, Placebo
- Keywords
- DHA, Omega-3, neoadjuvant chemotherapy, chemotherapy, breast cancer
- Medical subject headings
- Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADrug
Also called Docosahexaenoic Acid
4 capsules of 400 mg DHA daily
PlaceboDrug
Matched, blinded placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial acceptance
Number of potentially eligible subjects who consent to participate in the study.
Measured: 12 months
Subject retention and trial completion
Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.
Measured: Completion of study (~12 months)
Compliance with taking study agent.
Number of enrolled subjects who take at least 70% of prescribed study agent.
Measured: 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).
Measured: Completion of study (~12 months)
Secondary outcomes (6)
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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.
Measured: Month 12
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.
Measured: Change from Baseline to Month 12
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.
Measured: Change from Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2017
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517502
- Sponsor's protocol ID
- STUDY00002415
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2015
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Global results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
- ClinicalTrials.gov ID
- NCT02517502
- Acronym / sponsor ID
- STUDY00002415
- Conditions
- Cognitive Dysfunction
- Keywords
- DHA, Omega-3, neoadjuvant chemotherapy, chemotherapy, breast cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA | Experimental | Drug: DHAParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHAAlso: Docosahexaenoic Acid4 capsules of 400 mg DHA daily | Drug | DHA |
| PlaceboMatched, blinded placebo | Drug | Placebo |
Primary outcome
Trial acceptance
Time frame: 12 months
Number of potentially eligible subjects who consent to participate in the study.
Subject retention and trial completion
Time frame: Completion of study (~12 months)
Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.
Compliance with taking study agent.
Time frame: Completion of study (~12 months)
Number of enrolled subjects who take at least 70% of prescribed study agent.
Number of subjects reporting serious adverse events
Time frame: Completion of study (~12 months)
Number of enrolled subjects randomized to DHA who report serious adverse events (adjusted for subjects randomized to placebo who report serious adverse events).
6 secondary outcomes
Change in Cognitive Ability-General Concerns Questionnaire
Time frame: Baseline to Month 12
Change in Cognitive Ability-Abilities Questionnaire
Time frame: Baseline to Month 12
Change in Quality of Life Questionnaire
Time frame: Baseline to Month 12
Level of Physical Activity Questionnaire
Time frame: Month 12
Change in Cognitive Function test
Time frame: Change from Baseline to Month 12
Measurement of Cognitive Function Mobile Cognitive Assessment Battery (MCAB) Questionnaire
Time frame: Change from Baseline to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No. Global results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Fabian, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DHA in people with Cognitive Dysfunction, run by Carol Fabian, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial acceptance (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.