NCT04267874

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years – 77 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Carcinoma
• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of nasal swabs, blood, urine, and stool
DIETARY_SUPPLEMENT	Nutritional Supplementation	Given black raspberry nectar PO
DRUG	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-10-25
• Primary completion: 2021-05-13
• Completion: 2021-06-13
• First posted: 2020-02-13
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study