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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Carcinoma; Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Placebo Administration; Procedure: Biospecimen Collection; Dietary supplement: Nutritional Supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (BRB nectar, placebo, biospecimen collection); 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Placebo Administration; Given PO; Procedure: Biospecimen Collection; Undergo collection of nasal swabs, blood, urine, and stool; Dietary supplement: Nutritional Supplementation; Given black raspberry nectar PO; Other Names: supplementation
Experimental: Arm II (placebo, BRB nectar, biospecimen collection); 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.	Other: Questionnaire Administration; Ancillary studies; Drug: Placebo Administration; Given PO; Procedure: Biospecimen Collection; Undergo collection of nasal swabs, blood, urine, and stool; Dietary supplement: Nutritional Supplementation; Given black raspberry nectar PO; Other Names: supplementation

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Daniel Spakowicz, PhD, MS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Actual): May 13, 2021
• Study Completion (Actual): June 13, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: OSU-19007; NCI-2020-00418 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No