Clinical trial NCT01823991: COGNUTRIN in Breast Cancer Survivors
Official title: Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: polyphenolics
anthocyanins
n-3 fatty acids
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Gateway for Cancer Research
name: University of South Florida
First posted: 2013-04-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Cognitive Function Scores With Intervention - HVLT and COWA
timeFrame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
measure: Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2
timeFrame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
measure: Change in Cognitive Function Scores With Intervention - Digit Span
timeFrame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
measure: Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test
timeFrame: Baseline (Time 1) and at 3 months +/- 7 days (Time 2)
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 3 months from baseline +/- 7 days
measure: Occurrence of Adverse Events (AEs) by Causality
timeFrame: 3 months from baseline +/- 7 days
measure: Number of Participants Experiencing Grade 3 or Higher Adverse Events
timeFrame: 3 months from baseline +/- 7 days
measure: Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention
timeFrame: 3 months
Other outcomes:
measure: Change in Plasma Cytokines
timeFrame: 3 months
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Nagi Kumar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: