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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00418 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of nasal swabs, blood, urine, and stool |
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| 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 |
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Inclusion Criteria:
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Spakowicz, PhD, MS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2021 | Jun 30, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutritional Supplementation | Dietary Supplement | Given black raspberry nectar PO |
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| Placebo Administration | Drug | Given PO |
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| Questionnaire Administration | Other | Ancillary studies |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |