Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of CD8+, CD4+, and T-reg cells
研究概览
简要总结
This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients.
II. To evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients.
OUTLINE:
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics orally (PO) once on day 1, and then twice daily (BID) or three times daily (TID) for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age
- •Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery
- •Patients must have adequate organ function
- •Patients must be willing to provide tissue, blood and stool samples for the research study
排除标准
- •Patients must not receive systemic neoadjuvant therapy
- •Patients must not have taken any probiotics in the past 30 days prior to the enrollment
- •Patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded
研究组 & 干预措施
Supportive care (biospecimen collection, probiotic)
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics PO once on day 1, and then BID or TID for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
干预措施: Biopsy (Procedure)
Supportive care (biospecimen collection, probiotic)
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics PO once on day 1, and then BID or TID for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
干预措施: Biospecimen Collection (Procedure)
Supportive care (biospecimen collection, probiotic)
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics PO once on day 1, and then BID or TID for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
干预措施: Probiotic (Drug)
Supportive care (biospecimen collection, probiotic)
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics PO once on day 1, and then BID or TID for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Percentage of CD8+, CD4+, and T-reg cells
时间窗: Baseline up to 4 weeks
Length and adherence of probiotics
时间窗: Up to 4 weeks
Will be collected via study diaries.
Cytokine counts
时间窗: Baseline up to 4 weeks
次要结局
未报告次要终点