Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer

Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer

Sponsors

Lead Sponsor: Mayo Clinic

Collaborator: National Cancer Institute (NCI)

Source Mayo Clinic
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 (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.

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.

Overall Status Recruiting
Start Date 2021-07-01
Completion Date 2023-12-31
Primary Completion Date 2022-12-31
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Length of probiotics Up to 4 weeks
Adherence of probiotics Up to 4 weeks
Percentage of CD8+, CD4+, and T-reg cells Baseline up to 4 weeks
Cytokine counts Baseline up to 4 weeks
Enrollment 40
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Biopsy

Description: Undergo biopsy

Arm Group Label: Supportive care (biospecimen collection, probiotic)

Intervention Type: Procedure

Intervention Name: Biospecimen Collection

Description: Undergo collection of blood, stool, and tissue samples

Arm Group Label: Supportive care (biospecimen collection, probiotic)

Intervention Type: Dietary Supplement

Intervention Name: Probiotic

Description: Given PO

Arm Group Label: Supportive care (biospecimen collection, probiotic)

Intervention Type: Procedure

Intervention Name: Therapeutic Conventional Surgery

Description: Undergo standard of care surgery

Arm Group Label: Supportive care (biospecimen collection, probiotic)

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Saranya Chumsri Principal Investigator Mayo Clinic
Location
Facility: Status: Contact: Investigator: Mayo Clinic in Florida Clinical Trials Referral Office 855-776-0015 [email protected] Saranya Chumsri, M.D. Principal Investigator
Location Countries

United States

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Supportive care (biospecimen collection, probiotic)

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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