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NCT01823991 · ClinicalTrials.gov registry record · Early Phase 1
COGNUTRIN in Breast Cancer Survivors
A Early Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
NCT01823991: Completed Early Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01823991 is a Early Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 36 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01823991, a Early Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low \& high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard de
Interventions
- OTHER Placebo
- DRUG Lovaza®
- DRUG VitaBlue™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2018-05-02 |
| Phase | Early Phase 1 |
What the finished NCT01823991 record still lists
NCT01823991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01823991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01823991 about?
NCT01823991 is a clinical study titled "COGNUTRIN in Breast Cancer Survivors". 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 lat...
What is the current status of trial NCT01823991?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2014-07-30. Estimated completion is 2018-05-02.
What interventions are being tested in trial NCT01823991?
The interventions under investigation include: Placebo (OTHER), Lovaza® (DRUG), VitaBlue™ (DRUG).
Who is sponsoring clinical trial NCT01823991?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01823991's enrollment target sits among peer trials
36 712th of 2000 higher than 1,267 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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