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

Mayo Clinic

Status and phase: Completed; Early Phase 1

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

Treatments: Procedure: Biopsy; Procedure: Therapeutic Conventional Surgery; Procedure: Biospecimen Collection; Drug: Probiotic

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04857697

MC210302 (Other Identifier)

20-011177 (Other Identifier)

NCI-2021-03139 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Supportive care (biospecimen collection, probiotic)

Experimental group

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.

Treatment:

Procedure: Therapeutic Conventional Surgery

Drug: Probiotic

Procedure: Biospecimen Collection

Procedure: Biopsy