COGNUTRIN in Breast Cancer Survivors

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01823991

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

36

Starts

2014-07-30

Expected to finish

2018-05-02

Last updated by the study team

2020-07-14

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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