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

Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267874
• Other study ID #: OSU-19007
• Secondary ID: NCI-2020-00418
• Status: Completed
• Phase: Early Phase 1
• Start date: October 25, 2019
• Est. completion date: June 13, 2021

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lung Carcinoma
• Tobacco-Related Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Inflammatory markers found in nasal brushings	Evaluated by ribonucleic acid sequencing.	Up to 3 years
Primary	Changes in stool microbe relative abundances	Evaluated by metagenomic whole sequencing.	Up to 3 years
Primary	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

External Links

•   The Jamesline