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

NCT04267874 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-19007NCI-2020-00418
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma; Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Arm I (BRB nectar, placebo, biospecimen collection)

EXPERIMENTAL

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; Dietary Supplement: Nutritional Supplementation; Drug: Placebo Administration; Other: Questionnaire Administration

Arm II (placebo, BRB nectar, biospecimen collection)

EXPERIMENTAL

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; Dietary Supplement: Nutritional Supplementation; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of nasal swabs, blood, urine, and stool

Arm I (BRB nectar, placebo, biospecimen collection); Arm II (placebo, BRB nectar, biospecimen collection)

Nutritional Supplementation DIETARY_SUPPLEMENT

Given black raspberry nectar PO

Also known as: supplementation

Arm I (BRB nectar, placebo, biospecimen collection); Arm II (placebo, BRB nectar, biospecimen collection)

Placebo Administration DRUG

Given PO

Arm I (BRB nectar, placebo, biospecimen collection); Arm II (placebo, BRB nectar, biospecimen collection)

Questionnaire Administration OTHER

Ancillary studies

Arm I (BRB nectar, placebo, biospecimen collection); Arm II (placebo, BRB nectar, biospecimen collection)

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Daniel Spakowicz, PhD, MS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: October 25, 2019
• Primary Completion: May 13, 2021
• Study Completion: June 13, 2021
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)