Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-05 @ 12:07 PM
Study NCT ID:
NCT02517502
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
Sponsor:
Carol Fabian, MD
Organization:
Study Overview
Official Title:
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: