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

Primary Purpose

Lung Carcinoma, Tobacco-Related Carcinoma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Nutritional Supplementation
Placebo Administration
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Carcinoma

Eligibility Criteria

55 Years - 77 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (BRB nectar, placebo, biospecimen collection)

Arm II (placebo, BRB nectar, biospecimen collection)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Inflammatory markers found in nasal brushings
Evaluated by ribonucleic acid sequencing.
Changes in stool microbe relative abundances
Evaluated by metagenomic whole sequencing.
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).

Secondary Outcome Measures

Full Information

First Posted
February 11, 2020
Last Updated
July 4, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04267874
Brief Title
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
Official Title
The BE WELL Study: Black Raspberry Beverage Working to Prevent Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma, Tobacco-Related Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (BRB nectar, placebo, biospecimen collection)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (placebo, BRB nectar, biospecimen collection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo collection of nasal swabs, blood, urine, and stool
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplementation
Other Intervention Name(s)
supplementation
Intervention Description
Given black raspberry nectar PO
Intervention Type
Drug
Intervention Name(s)
Placebo Administration
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Recruitment rates
Description
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.
Time Frame
Up to 3 years
Title
Study adherence
Description
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.
Time Frame
Up to 3 years
Title
Inflammatory markers found in nasal brushings
Description
Evaluated by ribonucleic acid sequencing.
Time Frame
Up to 3 years
Title
Changes in stool microbe relative abundances
Description
Evaluated by metagenomic whole sequencing.
Time Frame
Up to 3 years
Title
Biologic responses to the black raspberry (BRB) nectar
Description
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).
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Spakowicz, PhD, MS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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