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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857697
• Other study ID #: MC210302
• Secondary ID: NCI-2021-0313920
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2021
• Est. completion date: March 8, 2023

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Adenocarcinoma
• Breast Neoplasms
• Lung Neoplasms
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Intervention

Procedure:
• Biopsy
Undergo biopsy
• Biospecimen Collection
Undergo collection of blood, stool, and tissue samples

Drug:
• Probiotic
Given PO

Procedure:
• Therapeutic Conventional Surgery
Undergo standard of care surgery

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length and adherence of probiotics	Will be collected via study diaries.	Up to 4 weeks
Primary	Percentage of CD8+, CD4+, and T-reg cells		Baseline up to 4 weeks
Primary	Cytokine counts		Baseline up to 4 weeks