Non Small Cell Lung Cancer Clinical Trial
Official title:
Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer
Verified date | February 2018 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.
Status | Terminated |
Enrollment | 6 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | James Graham Brown Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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