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

NCT04857697 | Completed Early Phase 1 FDA Drug

• 3 other identifiers: MC210302NCI-2021-0313920-011177
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Length and adherence of probiotics

  Will be collected via study diaries.

  Up to 4 weeks

• Percentage of CD8+, CD4+, and T-reg cells

  Baseline up to 4 weeks

• Cytokine counts

  Baseline up to 4 weeks

Study Arms (1)

Supportive care (biospecimen collection, probiotic)

EXPERIMENTAL

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.

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

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Supportive care (biospecimen collection, probiotic)

Biospecimen Collection PROCEDURE

Undergo collection of blood, stool, and tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected

Supportive care (biospecimen collection, probiotic)

Probiotic DRUG

Given PO

Supportive care (biospecimen collection, probiotic)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Supportive care (biospecimen collection, probiotic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biopsy; Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Saranya Chumsri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: July 1, 2021
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)