Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer
April 20, 2023 updated by: Mayo Clinic
Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- >= 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Undergo biopsy
Other Names:
Undergo standard of care surgery
Undergo collection of blood, stool, and tissue samples
Other Names:
Given PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length and adherence of probiotics
Time Frame: Up to 4 weeks
|
Will be collected via study diaries.
|
Up to 4 weeks
|
|
Percentage of CD8+, CD4+, and T-reg cells
Time Frame: Baseline up to 4 weeks
|
Baseline up to 4 weeks
|
|
|
Cytokine counts
Time Frame: Baseline up to 4 weeks
|
Baseline up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
March 8, 2023
Study Completion (Actual)
March 8, 2023
Study Registration Dates
First Submitted
April 21, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC210302
- NCI-2021-03139 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 20-011177 (Other Identifier: Mayo Clinic in Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.