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

This is a two-part open-label clinical trial of blueberry powder administered to patients with stage IV NSCLC in combination with docetaxel as a second line treatment. Patients will initially be enrolled in part 1 of the study, which is the feasibility/toxicity evaluation section of the study. Once the part I enrollment is completed, the patients will be enrolled in part 2 of the study.

Non-small Cell Lung Cancer

The intervention consists of 2-3 packages (15 grams per package) of lyophilized blueberry powder, taken daily after mixing with natural yogurt, milk, water, or juice in combination with set dosage of docetaxel (35 milligrams per meter squared) administered intravenously every week for 4 cycles, 21-day cycles.

Blueberry powder

James Graham Brown Cancer Center

Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer

Salvage Therapy With Docetaxel and Blueberry Powder in Non-Small Cell Lung Cancer

Completion of treatment plan by 10 patients. Feasibility and toxicity for the study will be evaluated in Part 1 of the study based on 10 patients completing the treatment plan (20 if 2 of the initial 10 patients develop toxicities).

Clinical response (complete, partial and sustained) rates will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines (version 1.1)

The cumulative number of toxic grade 3 or 4 events after each person is treated will be compared to the boundary outlined in the protocol. If the cumulative number of toxic events produces enough evidence to conclude that the true toxicity rate is greater then or equal to 33% (Pt0 = 0.33), then the trial will be stopped early for safety reasons.

Progression-free survival time defined as the time from enrollment until the first indication of disease progression or death due to any cause. Progression will be determined based on radiological measurements using RECIST criteria.

Overall Survival (OS) - time will be determined as the time from enrollment until death or last follow-up evaluation.

The changes in biomarker levels and their association with response assessments will be studied.

Functional Assessment of Cancer Therapy-Lung(FACT-L) questionnaire will be used to evaluate and measure quality of life.

Goetz Kloecker

Associate Professor

University of Louisville

PQG means Piperine, Quercetin and Genistein

Subjects will consume bread added with free curcumin

All participants followed all the periods

All Study Participants

Sex: Female, Male

Region of Enrollment

Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.

subjects consumed bread enriched with free curcumin

Free Curcumin

subjects consumed bread enriched with encapsulated curcumin

Encapsulated Curcumin

subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein

Encapsulated Curcumin + PQG

Control Cream

subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form

Free Cocoa Polyphenols

subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols

Encapsulated Cocoa Polyphenols

Serum Polyphenol Concentrations Over 24h From Food Consumption

Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.

subjects consumed bread containing encapsulated curcumin

subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)

subjects consumed nut creams added with cocoa polyphenols

Free Cocoa Polyphenol

Subjects consumed white bread or nut cream

Control

subjects consumed nut creams added with encapsulate cocoa-polyphenols

Subjects consumed bread added with free curcumin

Urinary Excretion of Total Polyphenols

Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.

Amount of Total Fecal Polyphenols

Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)

Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.

Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.

Subjects consumed 3 nut cream portions (33g each).

Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.

Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)

Free Then Encapsulated Curcumin (1 Day)

Washout Period of 1 Week

Encapsulated Then Free Curcumin (1 Day)

Enc Curc + PQG Then Free Polyph. (1 Day)

Free Polyph. Then Enc Curc + PQG (1 Day)

Enc Polyph. Then Control Cream (1 Day)

Control Cream Then Enc Polyph. (1 Day)

Prof. Vincenzo Fogliano

Healthy

free curcumin in bread, dosage 1g/100g, 200g/day per 1 day

free curcumin

encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day

encapsulated curcumin

bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day

encapsulated curcumin + PQG

nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day

free cocoa polyphenol

nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day

anthocyanidin/zhubný nádor

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

Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer

Physiological Effects of New Polyphenol-enriched Foods in Humans

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