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

NCT ID: NCT04857697

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-03-08

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Adenocarcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood, stool, and tissue samples

Probiotic

Intervention Type: DRUG

Given PO

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo standard of care surgery

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo collection of blood, stool, and tissue samples

Intervention Type: PROCEDURE

Probiotic

Given PO

Intervention Type: DRUG

Therapeutic Conventional Surgery

Undergo standard of care surgery

Intervention Type: PROCEDURE

Other Intervention Names

BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saranya Chumsri

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

NCI-2021-03139

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-011177

Identifier Type: OTHER

Identifier Source: secondary_id

MC210302

Identifier Type: -

Identifier Source: org_study_id