COGNUTRIN in Breast Cancer Survivors

NCT ID: NCT01823991

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-30
• Study Completion Date: 2018-05-02

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

COGNUTRIN (VITABLUE and n-3 fatty acids)

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.

Group Type: EXPERIMENTAL

VitaBlue™

Intervention Type: 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.

Lovaza®

Intervention Type: 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.

Placebo Administration

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

blueberry (BB) Anthocyanins; omega-3-acid ethyl esters

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gateway for Cancer Research

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagi Kumar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MCC-17089

Identifier Type: -

Identifier Source: org_study_id