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

STATUS

Recruiting
participants needed

42
sponsor

Ohio State University Comprehensive Cancer Center

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Updated on 19 February 2024

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cancer

vitamins

lung cancer

carcinoma

lung carcinoma

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.

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.

Details

Condition	Lung Neoplasm, Tobacco-Related Carcinoma
Age	55years - 77years
Treatment	Questionnaire Administration, Biospecimen Collection, Nutritional Supplementation, Placebo Administration
Clinical Study Identifier	NCT04267874
Sponsor	Ohio State University Comprehensive Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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. Any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker
	Agree to consume a standardized vitamin / mineral supplement and avoid other nutritional, dietary or alternative medications / supplements / probiotics for the duration of the study
	Agree to follow a berry-free / controlled phenolic diet and to document consumption of polyphenolic foods each day of the study using a simple daily form
Exclusion Criteria
	Person has an allergy to any berries, pectin, or food colorants apples,as well as kiwi fruit, 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 in the last 15 years OR
	Former smoker: not a current smoker active cigarette smoker who has smoked more than 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 connective tissues; or blood clotting disorders
	Person has allergy or food intolerance to ingredients in study products (black raspberries 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 the course of the study

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