Status:
COMPLETED
Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 (ope...
Detailed Description
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 prob...
Eligibility Criteria
Inclusion
- \>= 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04857697
Start Date
July 1 2021
End Date
March 8 2023
Last Update
April 21 2023
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980