H. Lee Moffitt Cancer Center and Research Institute
Who can join
Adults 40 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cognitive Function Scores With Intervention - HVLT and COWAPrimary· Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
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 deviation of 10. Any score below 50 indicates performance below population averages and any score abov
HVLT-total recall
Group
Value
95% CI
A - Cognutrin #1
49.04
± 6.41
B - Cognutrin #2
44.93
± 7.55
C - Placebo #1
42.28
± 4.21
D - Placebo #2
43.33
± 4.96
HVLT-delayed recall
Group
Value
95% CI
A - Cognutrin #1
44.82
± 5.33
B - Cognutrin #2
41.59
± 7.02
C - Placebo #1
47.49
± 3.5
D - Placebo #2
44.1
± 4.62
COWA-z score
Group
Value
95% CI
A - Cognutrin #1
-.341
± .686
B - Cognutrin #2
-.452
± .577
C - Placebo #1
-0.001
± 0.451
D - Placebo #2
0.332
± 0.379
Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2Primary· Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). Tests: Color Trails 1 \& Color Trails 2. Color Trails 1 consists of a page with scattered circles numbered from 1-25. Even numbered circles are colored yellow and odd numbered ones are colored pink. Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. Score is determined by recording the number of
Color Trails 1
Group
Value
95% CI
A - Cognutrin #1
59.82
± 11.5
B - Cognutrin #2
61.25
± 4.87
C - Placebo #1
47.47
± 2.89
D - Placebo #2
50.80
± 2.76
Color Trails 2
Group
Value
95% CI
A - Cognutrin #1
60.35
± 4.35
B - Cognutrin #2
60.57
± 4.64
C - Placebo #1
54.96
± 2.47
D - Placebo #2
59.97
± 2.63
Change in Cognitive Function Scores With Intervention - Digit SpanPrimary· Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
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 Digit Span assesses immediate verbal memory and auditory attention. The examiner reads increasingly longer series of numbers and the respondent is required to repeat them in the same order. The examiner then reads additional sequences of numbers and the respondent is required to repeat them in reverse order. Digit Span yields one score, number of items completed correctly. Scores ar
Group
Value
95% CI
A - Cognutrin #1
9.58
± 1.43
B - Cognutrin #2
12.69
± 1.75
C - Placebo #1
10.01
± .89
D - Placebo #2
10.05
± 1.09
Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities TestPrimary· Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Symbol Digit Modalities Test requires respondents to write the number that corresponds with each symbol for a series of 110 items in which the symbol but not the number appears. Respondents identify the correct number using a key provided in which symbols are matched with numbers. Total score is determined by calculating the number of items correctly completed in 9
Group
Value
95% CI
A - Cognutrin #1
.17
± .72
B - Cognutrin #2
.39
± .62
C - Placebo #1
.53
± .39
D - Placebo #2
.72
± .33
Number of Participants With Adverse Events (AEs)Secondary· 3 months from baseline +/- 7 days
The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the participant, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
10
Matching Placebo Twice a Day (BID)
4
Occurrence of Adverse Events (AEs) by CausalitySecondary· 3 months from baseline +/- 7 days
Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.
Definitely related to treatment
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
5
Matching Placebo Twice a Day (BID)
0
Probably related to treatment
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
1
Matching Placebo Twice a Day (BID)
0
Possibly related to treatment
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
0
Matching Placebo Twice a Day (BID)
0
Unlikely to be related to treatment
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
0
Matching Placebo Twice a Day (BID)
0
Unrelated to treatment
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
11
Matching Placebo Twice a Day (BID)
8
Number of Participants Experiencing Grade 3 or Higher Adverse EventsSecondary· 3 months from baseline +/- 7 days
The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the subject, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
0
Matching Placebo Twice a Day (BID)
0
Number of Participants With Improvement in Function MRI and Structural MRI Post-InterventionSecondary· 3 months
Functional: Improved cortical activation in multiple areas of the brain on examination of functional MRI post study intervention. Imaging including: 1) Extended resting state functional MRI with data post-processed on Philips EWS. Performed with patient's eyes closed and minds wandering. 2) Diffusion tensor imaging (DTI) with effective slice thickness of 2.3mm. Post-processed on Philips EWS with color-coded DTI tractography images obtained, absolute FA calculations performed in 9 anatomic areas in both right and left brain with total of 18 FA values obtained per examination. Structural: Improv
Functional MRI
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
2
Matching Placebo Twice a Day (BID)
0
Structural MRI
Group
Value
95% CI
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
0
Matching Placebo Twice a Day (BID)
0
Change in Plasma CytokinesSecondary· 3 months
Mean change plasma cytokines from baseline to post intervention with Cognutrin vs. placebo. Inflammatory markers-Cytokines were measured with a panel including IFN-g, IL-6, IL-8 and INF-alpha.
IFN-g
Group
Value
95% CI
A - Cognutrin #1
6.23
± 2.3
B - Cognutrin #2
8.3
± 2.48
C - Placebo #1
6.2
± 1.72
D - Placebo #2
4.64
± 1.85
IL-10
Group
Value
95% CI
A - Cognutrin #1
0.29
± 0.07
B - Cognutrin #2
0.2
± 0.03
C - Placebo #1
0.18
± 0.05
D - Placebo #2
0.22
± 0.03
IL-6
Group
Value
95% CI
A - Cognutrin #1
0.55
± 0.21
B - Cognutrin #2
2.07
± 1.05
C - Placebo #1
1.14
± 0.16
D - Placebo #2
1.5
± 0.78
IL-8
Group
Value
95% CI
A - Cognutrin #1
5.56
± 0.92
B - Cognutrin #2
8.55
± 2
C - Placebo #1
7.82
± 0.69
D - Placebo #2
8.02
± 1.49
INF-α
Group
Value
95% CI
A - Cognutrin #1
2.29
± 0.19
B - Cognutrin #2
2.53
± 0.36
C - Placebo #1
2.61
± 0.14
D - Placebo #2
2.61
± 2.61
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years, 10 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06148038 — CBD for Breast Cancer Primary Tumors
· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 14 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01823991.