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Herbal and Botanical

Docetaxel

Blueberry

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.

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

Goetz H Kloecker, MD

This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder, synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy will have a significant, positive effect in the response rate and overall survival.

This study is designed to evaluate the feasibility of using blueberry powder (rich in anthocyanidins) as an adjunct therapy with the conventional chemotherapy drug paclitaxel/docetaxel for treatment of NSCLC. The study is based on information from published studies in which blueberry anthocyanidins (bioflavonoids which give blueberries their color) have been shown to regulate a vast array of molecular targets, and on our own exciting and compelling preliminary data showing that blueberry anthocyanidins elicited potent synergistic chemo-sensitizing effects in two highly aggressive non-small cell lung cancer (NSCLC) cell lines.

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.

Spots Global Cancer Trial Database for blueberry powder