DHA
Drug4 capsules of 400 mg DHA daily
Other names: Docosahexaenoic Acid
NCT Number: NCT02517502
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.
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Notify Me18 year–65 year
Female
Interventional
Early Phase 1
Decatur Memorial Hospital, Decatur, Illinois, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 capsules of 400 mg DHA daily
Other names: Docosahexaenoic Acid
Matched, blinded placebo
Time frame: 12 months
Number of potentially eligible subjects who consent to participate in the study.
Time frame: Completion of study (~12 months)
Number of enrolled subjects who complete all cognitive assessments at all three defined timepoints.
Time frame: Completion of study (~12 months)
Number of enrolled subjects who take at least 70% of prescribed study agent.
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).
Time frame: Baseline to Month 12
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
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
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: Month 12
Physical activity will be tracked over course of the study. Participants will complete a physical activity questionnaire (PAQ-4) at each visit.
Time frame: Change from Baseline to Month 12
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
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.
Carol Fabian, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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