COGNUTRIN in Breast Cancer Survivors

NCT01823991 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: MCC-17089
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

polyphenolics; anthocyanins; n-3 fatty acids

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (Time 1) and at 3 months +/- 7 days (Time 2)

Secondary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  3 months from baseline +/- 7 days

• Occurrence of Adverse Events (AEs) by Causality

  3 months from baseline +/- 7 days

• Number of Participants Experiencing Grade 3 or Higher Adverse Events

  3 months from baseline +/- 7 days

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

  3 months

Other Outcomes (1)

• Change in Plasma Cytokines

  3 months

Study Arms (2)

COGNUTRIN (VITABLUE and n-3 fatty acids)

EXPERIMENTAL

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®

Placebo Administration

PLACEBO COMPARATOR

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

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.

Also known as: blueberry (BB) Anthocyanins

COGNUTRIN (VITABLUE and n-3 fatty acids)

Placebo OTHER

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 Administration

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.

Also known as: omega-3-acid ethyl esters

COGNUTRIN (VITABLUE and n-3 fatty acids)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days) (subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible to participate as this is standard of care for this patient population)
• Able to understand and sign the informed consent
• Fluent in reading, comprehension and communication in the English language
• No evidence of dementia - Mini Mental State Examination (MMSE) \>=23 but some evidence of cognitive impairment
• Must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts
• Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score \>60%)
• Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)
• Must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice

You may not qualify if:

• Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens, Raloxifene or Tamoxifen during the previous 3 months
• Use of over the counter steroid hormonal supplements including dehydroepiandrosterone (DHEA)
• Patients with advanced or Stage IIIIB or IV breast cancer or other cancers
• Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
• History of known allergy to components of the study supplements
• Renal or liver disease
• Concurrent participation in another chemoprevention trial
• Evidence of bleeding diathesis or coagulopathy
• Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.)
• Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging
• Medical history of concussions
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the potential participant inappropriate for entry into this study

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Gateway for Cancer Research: collaborator
• University of South Florida: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

blueberry extract; Anthocyanins; Omacor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Nagi Kumar
• Organization: H. Lee Moffitt Cancer Center and Research Institute

nagi.kumar@moffitt.org

813-745-6885

Study Officials

• Nagi Kumar, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: July 30, 2014
• Primary Completion: April 5, 2017
• Study Completion: May 2, 2018
• Last Updated: July 14, 2020
• Results First Posted: August 29, 2019

Record last verified: 2020-06

Locations

US (1)