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

Study Overview
=================
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.

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

Conditions
-----------------
Lung Carcinoma, Tobacco-Related Carcinoma

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Dietary Supplement: Nutritional Supplementation
* Drug: Placebo Administration
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 77 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (BRB nectar, placebo, biospecimen collection)<br>Patients receive BRB nectar PO 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. | Procedure: Biospecimen Collection<br>* Undergo collection of nasal swabs, blood, urine, and stool<br>Dietary Supplement: Nutritional Supplementation<br>* Given black raspberry nectar PO<br>* Other names: supplementation;Drug: Placebo Administration<br>* Given PO<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (placebo, BRB nectar, biospecimen collection)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of nasal swabs, blood, urine, and stool<br>Dietary Supplement: Nutritional Supplementation<br>* Given black raspberry nectar PO<br>* Other names: supplementation;Drug: Placebo Administration<br>* Given PO<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rates | Recruitment rates will be defined as the proportion of screened accrued relative to those approached. Successful recruitment rates will be defined as >= 10% of participants approached agree to participate. | Up to 3 years | 
| Study adherence | Study adherence will be defined as the percent of the biospecimens collected at the end of the study period, with a compliance goal of 60%. Will track the monthly collection of data and document reasons for missing any scheduled collection dates. The proportions of missing information at each time point will be calculated. Descriptive statistics will examine the distribution of all patient and treatment characteristics, overall and by patient and disease characteristics. | Up to 3 years | 
| Inflammatory markers found in nasal brushings | Evaluated by ribonucleic acid sequencing. | Up to 3 years | 
| Changes in stool microbe relative abundances | Evaluated by metagenomic whole sequencing. | Up to 3 years | 
| Biologic responses to the black raspberry (BRB) nectar | Samples of urine, stool. and blood will be analyzed for BRB phytochemicals (ellagitannins, ellagic acid, quercetin glycosides, anthocyanins) and their metabolites (urolithins, quercetin glucuronides/sulfates, methylated anthocyanins). | Up to 3 years |