Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Other Dietary Supplements

All Drugs and Chemicals

Flavonoid

Herbal and Botanical

Omega 3 Fatty Acid

Anthocyanidin

Blueberry

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.

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.

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.

VitaBlue™

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.

Placebo

Lovaza®

Nagi Kumar, Ph.D.

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.

COGNUTRIN in Breast Cancer Survivors

Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors

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.

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.

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.

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.

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.

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.

Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.

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.

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)

Gateway for Cancer Research

University of South Florida

H. Lee Moffitt Cancer Center and Research Institute

Self administration of nutritional supplement COGNUTRIN for 3 months.

Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)

Self administration of placebo for 3 months.

Matching Placebo Twice a Day (BID)

Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.

VitaBlue™: 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.

Lovaza®: 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.

COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID)

Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.

Placebo: 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.

Matching Placebo BID

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The main reason for not completing baseline or post intervention MRI were: (a) Claustrophobia or fear of being in an MRI and (b) metal bands in breast in preparation for to breast reconstruction that prohibited these participants being in MRI.

Dr. Nagi Kumar

HVLT-total recall

HVLT-delayed recall

COWA-z score

A - Cognutrin #1

B - Cognutrin #2

C - Placebo #1

D - Placebo #2

All evaluable participants at time of analysis.

Change in Cognitive Function Scores With Intervention - HVLT and COWA

Color Trails 1

Color Trails 2

Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2

Change in Cognitive Function Scores With Intervention - Digit Span

Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test

All evaluable participants who received treatment.

Number of Participants With Adverse Events (AEs)

Definitely related to treatment

Probably related to treatment

Possibly related to treatment

Unlikely to be related to treatment

Unrelated to treatment

Occurrence of Adverse Events (AEs) by Causality

Evaluable participants who received treatment.

Number of Participants Experiencing Grade 3 or Higher Adverse Events

Functional MRI

Structural MRI

All participants with both pre- and post-therapy brain MRI examinations.

Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention

IFN-g

IL-10

IL-6

IL-8

INF-α

All evaluable participants at time of analysis

Change in Plasma Cytokines

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.

VitaBlue™: 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.

Lovaza®: 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.

Participants will be provided with two bottles containing placebos. Participants will be asked to take 1 tablet of placebo two times a day and 1 tablet of or placebo three times a day.

Placebo: 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.

Spots Global Cancer Trial Database for COGNUTRIN in Breast Cancer Survivors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial