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Phase II - Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors

Phase 2
45 Years
75 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II - Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors

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.

Inclusion Criteria:

- Cases with Stage I-IIIA Breast Cancer treated with anthracyclines and taxanes (within
90 days)

- Able to understand and sign the informed consent

- Intact vision (visual acuity 20/40)

- Native English-speaking

- 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

- Concurrent use of Coumadin or warfarin will be acceptable and monitoring patients on
warfarin or Coumadin will follow the standard of care as dictated by the prescribing

- Must be willing to be monitored for adequacy of nutritional intake during the
intervention, as is the current standard of clinical practice. Menopausal status will
be obtained from all subjects. (Chemotherapy related amenorrhea will be defined as
without menstrual periods for a period equal to or over 6 months in a patient who was
premenopausal at diagnosis).

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

- 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

- Mental illness judged by the Principal Investigator (PI) to preclude a successful
completion of the trial

- Concurrent participation in another chemoprevention trial

- Persons who are not native English speakers are excluded from the current proposal
because many of the cognitive tests that are administered are language-based and are
heavily influenced by first language.

- Evidence of bleeding diathesis or coagulopathy

- 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 subject inappropriate for entry into this

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Number of Impaired Neuropsychological Tests

Outcome Description:

The primary efficacy endpoint is to compare the number of impaired neuropsychological tests. The planned intervention period is three months. Neuropsychological outcomes will be examined using a 2 (group; COGNUTRIN, placebo) X 2 (time; baseline, three-months) repeated measures ANOVA to functioning, depression and fatigue will be evaluated for association with neurocognitive performance and entered as covariates in statistical analyses if a marginally significant association (p<.10) is observed. Changes in cognitive function: Number of impaired neuropsychological tests after 3 months of intervention with COGNUTRIN vs. placebo.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Nagi Kumar, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • polyphenolics
  • anthocyanins
  • n-3 fatty acids
  • Breast Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612