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

Phase

Condition

Carcinoma

Treatment

Questionnaire Administration

Placebo Administration

Biospecimen Collection

Clinical Study ID

NCT04267874

OSU-19007

NCI-2020-00418

Ages 55-77
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Have a 30 pack-year smoking history
Be either a current smoker or a former smoker that quit in the last 15 years. Anyindividual who is currently smoking and has smoked more than 100 cigarettes in theirlifetime will be identified as a current smoker
Agree to consume a standardized vitamin / mineral supplement and avoid othernutritional, dietary or alternative medications / supplements / probiotics for theduration of the study
Agree to follow a berry-free / controlled phenolic diet and to document consumption ofpolyphenolic foods each day of the study using a simple daily form

Exclusion

Exclusion Criteria:

Person has an allergy to any berries, pectin, or food colorants apples,as well as kiwifruit, strawberries, soy sauce, pine nuts, almonds, cherries, peaches, blackberries,pears
Person states that they are not a:
Current smoker: active cigarette smoker who has smoked more than 30 pack-years inthe last 15 years OR
Former smoker: not a current smoker active cigarette smoker who has smoked morethan 30 pack years in the last 15 years
Person is unwilling to follow a berry-free/controlled polyphenol diet while on study
Person has history of metabolic disorders (diabetes, hyper/hypo-thyroidism, etc.);digestive illness which may result in nutrient malabsorption (Crohn's disease, Celiac,renal/hepatic insufficiency, short bowel, etc.); disorders that affect connectivetissues; or blood clotting disorders
Person has allergy or food intolerance to ingredients in study products (blackraspberries or other berries)
Person is on a regimen of any of the following medications:
Immunosuppressants, bisphosphonates, or steroids.
Anticoagulants (warfarin, apixaban, dabigatran, and rivaroxaban)
Probiotics
Person is undergoing treatment for cancer in any form
Person is currently pregnant or nursing or plans to become pregnant during this study
Person plans to enter smoking cessation or change their smoking status during thecourse of the study

Study Design

Questionnaire Administration

October 25, 2019

June 13, 2021

Study 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.

Connect with a study center

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Site Not Available

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