The Effect of Berries on Lung Cancer Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.

Detailed Description
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In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers. Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries. The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

Official Title
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Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Dietary Supplement: berry powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (lung cancer survivors): men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women) Exclusion Criteria (lung cancer survivors): women who are on hormone replacement therapy women who are pregnant, or planning for pregnancy history of lung transplant prison inmate inability to take oral medication or food known or suspected allergy to berries or berry products HIV patients Inclusion Criteria (volunteers): adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women) Exclusion Criteria (volunteers): women who are on hormone replacement therapy women who are pregnant, or planning for pregnancy history of lung transplant prison inmate inability to take oral medication or food known or suspected allergy to berries or berry products HIV patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: berry powder|All subjects (lung cancer survivors and volunteers) will consume 20 grams of berry powder (blueberries, black raspberries, or a mixture of both) per day by mouth for the first 3 days, then 40 grams of berry powder by mouth every day for 4 to 5 weeks. The berry powder is to be mixed in subject's routine intake of milk, yogurt, juice, or water. All subjects will have the option to continue the berry regimen for an extended period. Subjects who choose to do so will not consume any berry powder for one week. After one week, subjects will begin consuming 40 grams of the berry powder every day for an additional 4 to 5 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of blueberry and black raspberry phenolics in plasma and urine | In addition to determining the berry phytochemical profile in plasma and urine, this study will attempt to establish the effect of berries on modulating immunological profiles such as the complete blood count, and T, B and natural killer (NK) cell populations and circulating biomarkers (serum proteins and microRNAs). This pilot study will establish the safety and feasibility of conducting a larger clinical trial with berry intervention. | upon completion of 4 to 5 weeks of daily consumption of berry powder | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, lung cancer, non small cell lung cancer, lung carcinoma