An Early Phase 1 interventional study of VitaBlue™ and Placebo in Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Early Phase 1, Interventional, and Supportive care
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.
This pilot study will evaluate the feasibility of administration of the nutritional supplement and placebo in this patient population and performing cognitive function testing at baseline and post supplementation.
This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.
Participants have an equal chance (like flipping a coin) of being in either of the study groups. Neither the participant nor the study doctor will be able to choose which study group the participant is in. Participants will not know and the study doctor will not know which study group the participants are in.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be provided with two bottles containing Lovaza and VitaBlue. Participants will be asked to take 1 tablet of Lovaza two times a day and 1 tablet of VitaBlue three times a day.
Drug: VitaBlue™ · Drug: Lovaza®
Participants will be provided with two bottles containing placebo. Participants will be asked to take 1 tablet of one placebo two times a day and 1 tablet of other placebo three times a day.
Other: Placebo
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.
Also known as: blueberry (BB) Anthocyanins
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.
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.
Also known as: omega-3-acid ethyl esters
Change in Cognitive Function Scores With Intervention - HVLT and COWA
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 above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor fluency.
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Color Trails 1 & 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 seconds required to complete the task. Color Trails 2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1-60. Respondents are instructed to connect circles in consecutive order while alternating colors. A total score is determined by recording the number of seconds required to compete the task.
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Digit Span
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 are scaled from the Wechsler Adult Intelligence Scale. The values for these scaled scores indicated that values from 1-7 indicate below average performance, corresponding to 1-16 percentile ranks. Scores between 8-12 indicate average performance, corresponding to percentile ranks of 25-75. Scores between 13-19 correspond to areas of strength and 84-99 percentile ranks.
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test
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 90 seconds Scale uses z-scores which have a mean of 0 and a standard deviation of 1. Scores cores above 0 indicate better than average performance whereas scores below 0 indicate poorer than average performance.
Time frame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Number of Participants With Adverse Events (AEs)
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.
Time frame: 3 months from baseline +/- 7 days
Occurrence of Adverse Events (AEs) by Causality
Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.
Time frame: 3 months from baseline +/- 7 days
Number of Participants Experiencing Grade 3 or Higher Adverse Events
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.
Time frame: 3 months from baseline +/- 7 days
Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention
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: Improved white matter signal changes which correlate with ischemic changes or microvascular ischemic changes, cortical atrophy, hippocampal atrophy, brain volume and gray-white matter ratio. Anatomic sequences including: 1) Coronal 3-D volume T1 weighted gradient echo images with effective slice thickness of 1mm. 2) Axial FLAIR (fluid attenuated inversion recovery)
Time frame: 3 months
Change in Plasma Cytokines
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.
Time frame: 3 months
Participants were enrolled at Moffitt Cancer Center between July 2014 and February 2017.
| Milestone | COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID) | Matching Placebo BID |
|---|---|---|
| Started | 18 | 18 |
| Completed | 10 | 13 |
| Not completed | 8 | 5 |
| Withdrew: Withdrawal by subject | 8 | 5 |
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 above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor fluency.
| score | A - Cognutrin #1 | B - Cognutrin #2 | C - Placebo #1 | D - Placebo #2 |
|---|---|---|---|---|
| HVLT-total recall | 49.04 ± 6.41 | 44.93 ± 7.55 | 42.28 ± 4.21 | 43.33 ± 4.96 |
| HVLT-delayed recall | 44.82 ± 5.33 | 41.59 ± 7.02 | 47.49 ± 3.5 | 44.1 ± 4.62 |
| COWA-z score | -.341 ± .686 | -.452 ± .577 | -0.001 ± 0.451 | 0.332 ± 0.379 |
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 seconds required to complete the task. Color Trails 2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1-60. Respondents are instructed to connect circles in consecutive order while alternating colors. A total score is determined by recording the number of seconds required to compete the task.
| seconds | A - Cognutrin #1 | B - Cognutrin #2 | C - Placebo #1 | D - Placebo #2 |
|---|---|---|---|---|
| Color Trails 1 | 59.82 ± 11.5 | 61.25 ± 4.87 | 47.47 ± 2.89 | 50.80 ± 2.76 |
| Color Trails 2 | 60.35 ± 4.35 | 60.57 ± 4.64 | 54.96 ± 2.47 | 59.97 ± 2.63 |
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 are scaled from the Wechsler Adult Intelligence Scale. The values for these scaled scores indicated that values from 1-7 indicate below average performance, corresponding to 1-16 percentile ranks. Scores between 8-12 indicate average performance, corresponding to percentile ranks of 25-75. Scores between 13-19 correspond to areas of strength and 84-99 percentile ranks.
| score | A - Cognutrin #1 | B - Cognutrin #2 | C - Placebo #1 | D - Placebo #2 |
|---|---|---|---|---|
| Change in Cognitive Function Scores With Intervention - Digit Span | 9.58 ± 1.43 | 12.69 ± 1.75 | 10.01 ± .89 | 10.05 ± 1.09 |
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 90 seconds Scale uses z-scores which have a mean of 0 and a standard deviation of 1. Scores cores above 0 indicate better than average performance whereas scores below 0 indicate poorer than average performance.
| score | A - Cognutrin #1 | B - Cognutrin #2 | C - Placebo #1 | D - Placebo #2 |
|---|---|---|---|---|
| Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test | .17 ± .72 | .39 ± .62 | .53 ± .39 | .72 ± .33 |
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.
| Participants | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 10 | 4 |
Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.
| Adverse Events | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| Definitely related to treatment | 5 | 0 |
| Probably related to treatment | 1 | 0 |
| Possibly related to treatment | 0 | 0 |
| Unlikely to be related to treatment | 0 | 0 |
| Unrelated to treatment | 11 | 8 |
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.
| participants | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| Number of Participants Experiencing Grade 3 or Higher Adverse Events | 0 | 0 |
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: Improved white matter signal changes which correlate with ischemic changes or microvascular ischemic changes, cortical atrophy, hippocampal atrophy, brain volume and gray-white matter ratio. Anatomic sequences including: 1) Coronal 3-D volume T1 weighted gradient echo images with effective slice thickness of 1mm. 2) Axial FLAIR (fluid attenuated inversion recovery)
| Participants | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| Functional MRI | 2 | 0 |
| Structural MRI | 0 | 0 |
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.
| pg/mL | A - Cognutrin #1 | B - Cognutrin #2 | C - Placebo #1 | D - Placebo #2 |
|---|---|---|---|---|
| IFN-g | 6.23 ± 2.3 | 8.3 ± 2.48 | 6.2 ± 1.72 | 4.64 ± 1.85 |
| IL-10 | 0.29 ± 0.07 | 0.2 ± 0.03 | 0.18 ± 0.05 | 0.22 ± 0.03 |
| IL-6 | 0.55 ± 0.21 | 2.07 ± 1.05 | 1.14 ± 0.16 | 1.5 ± 0.78 |
| IL-8 | 5.56 ± 0.92 | 8.55 ± 2 | 7.82 ± 0.69 | 8.02 ± 1.49 |
| INF-α | 2.29 ± 0.19 | 2.53 ± 0.36 | 2.61 ± 0.14 | 2.61 ± 2.61 |
Collected over 2 years, 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | 0/18 (0%) | 1/18 (5.6%) | 10/18 (55.6%) |
| Matching Placebo Twice a Day (BID) | 0/18 (0%) | 0/18 (0%) | 4/18 (22.2%) |
| Event | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| PsychosisPsychiatric disorders | 1/18 | 0/18 |
| Event | Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID) | Matching Placebo Twice a Day (BID) |
|---|---|---|
| NauseaGastrointestinal disorders | 3/18 | 1/18 |
| Gastrointestinal disorders - OtherGastrointestinal disorders | 3/18 | 0/18 |
| VomitingGastrointestinal disorders | 2/18 | 0/18 |
| Flu like symptomsGeneral disorders | 2/18 | 0/18 |
| Abdominal painGastrointestinal disorders | 0/18 | 1/18 |
| ConstipationGastrointestinal disorders | 1/18 | 0/18 |
| DiarrheaGastrointestinal disorders | 1/18 | 0/18 |
| ChillsGeneral disorders | 1/18 | 0/18 |
| Edema limbsGeneral disorders | 1/18 | 0/18 |
| PainGeneral disorders | 1/18 | 0/18 |
All Participants.
| Age, Continuous(years) | COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID) | Matching Placebo BID | Total |
|---|---|---|---|
| Mean | 43.7 ± 4.85 | 50.92 ± 6.17 | 46 ± 7.9 |
| Sex: Female, Male(Participants) | COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID) | Matching Placebo BID | Total |
|---|---|---|---|
| Female | 18 | 18 | 36 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID) | Matching Placebo BID | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 16 | 15 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID) | Matching Placebo BID | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
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H. Lee Moffitt Cancer Center and Research Institute