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Spots Global Cancer Trial Database for Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study

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Trial Identification

Brief Title: Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study

Official Title: The BE WELL Study: Black Raspberry Beverage Working to Prevent Lung Cancer

Study ID: NCT04267874

Study Description

Brief Summary: This trial studies how well black raspberry nectar works in changing the gut microbiome and in reducing inflammatory processes that may lead to lung cancer. Studying the effects of black raspberry beverage on inflammation may help doctors find strategies to reduce the risk of developing lung cancer.

Detailed Description: PRIMARY FEASIBILITY OBJECTIVE: I. To evaluate the feasibility of establishing a diet intervention trial with longitudinal microbiome collection in Ohio State University Comprehensive Cancer Center (OSUCCC) Lung Cancer Screening Clinic (OSUCCC-LCSC). PRIMARY SCIENTIFIC OBJECTIVE: I. To determine the impact of the black raspberry (BRB) nectar intervention on the microbiome and inflammatory biomarkers. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive BRB nectar orally (PO) twice daily (BID) for weeks 0-4 and then receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10. ARM II: Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

Keywords

Eligibility

Minimum Age: 55 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Contact Details

Name: Daniel Spakowicz, PhD, MS

Affiliation: Ohio State University Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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