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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04857697
Collaborator
National Cancer Institute (NCI) (NIH)
40
Enrollment
1
Location
1
Arm
30
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Drug: Probiotic
  • Procedure: Therapeutic Conventional Surgery
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

    • Procedure: Biospecimen Collection
    Undergo collection of blood, stool, and tissue samples
    Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

    • Drug: Probiotic
    Given PO

    Procedure: Therapeutic Conventional Surgery
    Undergo standard of care surgery

    Outcome Measures

    Primary Outcome Measures

    1. Length and adherence of probiotics [Up to 4 weeks]

      Will be collected via study diaries.

    2. Percentage of CD8+, CD4+, and T-reg cells [Baseline up to 4 weeks]

    3. Cytokine counts [Baseline up to 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Saranya Chumsri, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04857697
    Other Study ID Numbers:
    • 20-011177
    • NCI-2021-03139
    • 20-011177
    • P30CA015083
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Lung Neoplasms

    Study Results

    No Results Posted as of May 9, 2022