Clinical trial NCT04267874: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lung Carcinoma
Tobacco-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 96
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recruitment rates
timeFrame: Up to 3 years
measure: Study adherence
timeFrame: Up to 3 years
measure: Inflammatory markers found in nasal brushings
timeFrame: Up to 3 years
measure: Changes in stool microbe relative abundances
timeFrame: Up to 3 years
measure: Biologic responses to the black raspberry (BRB) nectar
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Daniel Spakowicz, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: