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

Early Phase 1

Completed

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Adenocarcinoma; Stage I Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8
• Interventions: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Probiotic; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT04857697
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2021-07-01
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (biospecimen collection, probiotic)	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.
Supportive care (biospecimen collection, probiotic)	Therapeutic Conventional Surgery	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.
Supportive care (biospecimen collection, probiotic)	Biopsy	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.
Supportive care (biospecimen collection, probiotic)	Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
Percentage of CD8+, CD4+, and T-reg cells	Baseline up to 4 weeks
Length and adherence of probiotics	Up to 4 weeks	Will be collected via study diaries.
Cytokine counts	Baseline up to 4 weeks

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States