The BE WELL Study: Black Raspberry Beverage Working to Prevent Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Inflammatory markers found in nasal brushings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (BRB nectar, placebo, biospecimen collection)
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.
干预措施: Biospecimen Collection (Procedure)
Arm I (BRB nectar, placebo, biospecimen collection)
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.
干预措施: Nutritional Supplementation (Dietary Supplement)
Arm I (BRB nectar, placebo, biospecimen collection)
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.
干预措施: Placebo Administration (Drug)
Arm I (BRB nectar, placebo, biospecimen collection)
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.
干预措施: Questionnaire Administration (Other)
Arm II (placebo, BRB nectar, biospecimen collection)
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.
干预措施: Biospecimen Collection (Procedure)
Arm II (placebo, BRB nectar, biospecimen collection)
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.
干预措施: Nutritional Supplementation (Dietary Supplement)
Arm II (placebo, BRB nectar, biospecimen collection)
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.
干预措施: Placebo Administration (Drug)
Arm II (placebo, BRB nectar, biospecimen collection)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Inflammatory markers found in nasal brushings
时间窗: Up to 3 years
Evaluated by ribonucleic acid sequencing.
Recruitment rates
时间窗: Up to 3 years
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
时间窗: Up to 3 years
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.
Changes in stool microbe relative abundances
时间窗: Up to 3 years
Evaluated by metagenomic whole sequencing.
Biologic responses to the black raspberry (BRB) nectar
时间窗: Up to 3 years
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).
次要结局
未报告次要终点
研究者
Daniel Spakowicz
Principal Investigator
Ohio State University Comprehensive Cancer Center