CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 36 enrolled
Drug / intervention
VitaBlue™ +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01823991
NCT01823991Early Ph 1Completed
CompareCT.gov

Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Apr 4, 2013·Updated Jul 14, 2020

In Brief

A Early Phase 1 clinical trial evaluating VitaBlue™, Placebo, and 1 other intervention for Breast Cancer. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the safety and influence of an intervention (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on cognitive performance in breast cancer survivors following chemotherapy. The investigators' goal is to treat or lessen the late effects of cancer treatment. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGateway for Cancer Research, University of South Florida

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartJul 30, 2014
Primary CompletionApr 5, 2017
Study CompletionMay 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.2 years ago

Interventions

VitaBlue™drug

Self administration of nutritional supplement COGNUTRIN for 3 months. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.

Placeboother

Self administration of placebo for 3 months. Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people.

Lovaza®drug

Self administration of nutritional supplement COGNUTRIN for 3 months. The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.