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

This study is currently recruiting participants.
Verified on August 2011 by James Graham Brown Cancer Center

First Received on August 27, 2011.  
Last Updated on August 30, 2011  
History of Changes
This Clinical Trial Sponsored By: James Graham Brown Cancer Center
Information provided by (Responsible Party): Goetz Kloecker, MD, James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01426620
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Non-small Cell Lung Cancer Dietary Supplement: Blueberry powder Phase II

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salvage Therapy With Docetaxel and Blueberry Powder in Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Docetaxel

U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures For Clinical Trial:

  • Proportion of patients successfully completing the entire treatment plan [ Time Frame: 2 years after study enrollment ] [ Designated as safety issue: Yes ]
    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 patintents completing the treatment plan(20 if 2 of the intial 10 patients develop toxicities)

  • Clinical Response Rate [ Time Frame: 16 months after last treatment ] [ Designated as safety issue: No ]
    Clinical response (complete, partial and sustained) rates will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) Guidlines (version 1.1)

Secondary Outcome Measures For Clinical Trial:

  • Cumulative number of grade 3 or 4 toxic events [ Time Frame: 2 years after study enrollment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The changes in biomarker levels and their association with reponse assessments will be studied.

  • Quality of Life FACT-L measurement [ Time Frame: 2 years after study enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Blueberry powder: Experimental

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.
Study Intervention: Dietary Supplement: Blueberry powder
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent prior to screening
  2. Male or female patients, age ≥ 18 years
  3. Histologically or cytologically confirmed diagnosis of NSCLC
  4. Stage IV disease (including patients with pleural effusion previously classified as Stage IIIB)
  5. All of the following if patient has had prior radiation therapy:

    • lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy
    • the patient has recovered from any acute effects of the radiotherapy
    • radiotherapy was completed at least 4 weeks prior to screening
  6. Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)
  7. Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 10 millimeters (mm) on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 20 mm by standard techniques; positron emissions tomography [PET] and ultrasound are not permitted methods for tumor measurements under this protocol.
  8. Performance status of 0 or 2 on the ECOG Performance Status Scale
  9. Have an estimated life expectancy of at least 12 weeks
  10. Adequate organ function within 14 days prior to first berry powder dose or docetaxel whichever occurs first, including the following – absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platel

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