intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins

intake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs

Toxicity Due to Radiotherapy

Placebo

intake anthocyanin-rich corn extract

Department of Radiotherapy

Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer

Prevention of side effects - skin toxicity - of radiotherapy

Secondary end-points are late toxicity, cosmetic results, local control, and survival.

Blood cells count, markers of plasma and cell oxidation, markers of inflammatory response and oxidative DNA damage

Anthocyanins excretion will be evaluated in urine samples by analytical techniques.

late toxicity, cosmetic results, local control, and survival

Maria Benedetta Donati

head laboratory

Neuromed IRCCS

Cyclophosphamide- Epirubicin 6 course regimen to be used with Jobelyn

Routine drugs for treatment of Breast Cancer used with Placebo

Haematological Abnormality

Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6

Jobelyn + Cyclophosphamide-Epirubicin6

Routine drugs for the treatment of breast cancer to be used with Placebo

Placebo + Cyclophosphamide - Epirubicin 6

Lagos State University Teaching Hospital

Lagos State University

The Safety and Efficacy of Jobelyn in the Treatment of Breast Cancer Patients

A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients.

Evaluation of the expression of activated natural killer cells CD3-CD56+CD69+ after treatment with Jobelyn

Subjects would use form Safety Fractor-36 to score aspects of well-being

Changes in levels of hematocrit after treatment with Jobelyn

Abiodun Popoola

CONSULTANT IN THE DEPARTMENT OF ONCOLOGY LASUTH

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.

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.

Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.
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.
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.

COGNUTRIN (n-3 Fatty Acids + Anthocynins) Twice a Day (BID)

Participants will be provided with two bottles containing Lovaza (or placebo) and VitaBlue (or placebo). Participants will be asked to take 1 tablet of Lovaza (or placebo) two times a day and 1 tablet of VitaBlue (or placebo) three times a day.
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.

Matching Placebo BID

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

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.

A - Cognutrin #1

B - Cognutrin #2

C - Placebo #1

D - Placebo #2

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 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.

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. 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.

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 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.

Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test

The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the participant, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.

Self administration of nutritional supplement COGNUTRIN for 3 months.

Cognutrin (n-3 Fatty Acids + Anthocyanins) Twice a Day (BID)

Self administration of placebo for 3 months.

Matching Placebo Twice a Day (BID)

Number of Participants With Adverse Events (AEs)

Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.

Occurrence of Adverse Events (AEs) by Causality

The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the subject, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.

Number of Participants Experiencing Grade 3 or Higher Adverse Events

Functional: Improved cortical activation in multiple areas of the brain on examination of functional MRI post study intervention. Imaging including: 1) Extended resting state functional MRI with data post-processed on Philips EWS. Performed with patient's eyes closed and minds wandering. 2) Diffusion tensor imaging (DTI) with effective slice thickness of 2.3mm. Post-processed on Philips EWS with color-coded DTI tractography images obtained, absolute FA calculations performed in 9 anatomic areas in both right and left brain with total of 18 FA values obtained per examination. Structural: Improved white matter signal changes which correlate with ischemic changes or microvascular ischemic changes, cortical atrophy, hippocampal atrophy, brain volume and gray-white matter ratio. Anatomic sequences including: 1) Coronal 3-D volume T1 weighted gradient echo images with effective slice thickness of 1mm. 2) Axial FLAIR (fluid attenuated inversion recovery)

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

Mean change plasma cytokines from baseline to post intervention with Cognutrin vs. placebo. Inflammatory markers-Cytokines were measured with a panel including IFN-g, IL-6, IL-8 and INF-alpha.

Change in Plasma Cytokines

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.
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.
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.

Participants will be provided with two bottles containing placebos. Participants will be asked to take 1 tablet of placebo two times a day and 1 tablet of or placebo three times a day.
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.

Overall Study

Dr. Nagi Kumar

Breast Cancer

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.

VitaBlue™

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.

Lovaza®

Moffitt Cancer Center Clinical Trials website

H. Lee Moffitt Cancer Center and Research Institute

COGNUTRIN in Breast Cancer Survivors

Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors

Gateway for Cancer Research

University of South Florida

RayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

Reduced glutathione

Legacy Health System

RayGel-An Alternative for Skin Care During External Beam Radiation

Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.

Skin reaction scale along with evaluation by radiation oncologist at weekly intervals from start of radiation therapy until completion of radiation.

anthocyanin/karcinóm prsníka

Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer

The Safety and Efficacy of Jobelyn in the Treatment of Breast Cancer Patients

COGNUTRIN in Breast Cancer Survivors

RayGel-An Alternative for Skin Care During External Beam Radiation

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