Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer (BIT-2)
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|ClinicalTrials.gov Identifier: NCT01426620|
Recruitment Status : Terminated (slow accrual)
First Posted : August 31, 2011
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Dietary Supplement: Blueberry powder||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salvage Therapy With Docetaxel and Blueberry Powder in Non-Small Cell Lung Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Blueberry powder
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.
Dietary Supplement: Blueberry powder
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.
- Proportion of patients successfully completing the entire treatment plan [ Time Frame: 2 years after study enrollment ]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 Rate [ Time Frame: 16 months after last treatment ]Clinical response (complete, partial and sustained) rates will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines (version 1.1)
- Cumulative number of grade 3 or 4 toxic events [ Time Frame: 2 years after study enrollment ]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 (PFS) time [ Time Frame: 16 months after last treatment ]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 Frame: 2 years after time of enrollment of last participant ]Overall Survival (OS) - time will be determined as the time from enrollment until death or last follow-up evaluation.
- Change in biomarker levels, measured by blood tests taken throughout the study [ Time Frame: 2 years after study enrollment ]The changes in biomarker levels and their association with response assessments will be studied.
- Quality of Life FACT-L measurement [ Time Frame: 2 years after study enrollment ]Functional Assessment of Cancer Therapy-Lung(FACT-L) questionnaire will be used to evaluate and measure quality of life.
- Measure the change in berry polyphenolic levels by blood tests throughout the study [ Time Frame: 2 years after study enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426620
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Goetz H Kloecker, MD||James Graham Brown Cancer Center|