Gut Microbiome & Gastrointestinal Toxicities as Determinants of Response to Neoadjuvant Chemo for Advanced Breast Cancer

Purpose

The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective.

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with invasive breast cancer and prescribed a regimen that includes neo-adjuvant therapy prior to breast surgery.
  • Able to provide informed consent.

Exclusion Criteria

  • History of previous malignancy, other than non-melanoma skin cancers
  • Inability to tolerate phlebotomy
  • Immunosuppressive therapy for any other condition
  • Fever or active uncontrolled infection in the last 4 weeks
  • Inflammatory bowel disease
  • Surgery of the stomach, small or large intestines, appendectomy, gastric bypass or gastric banding in the past 6 months.
  • Active autoimmune disease, including, but not limited to, Systemic lupus erythematosus (SLE), Multiple sclerosis (MS), ankylosing spondylitis

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Blood & Fecal Collection
Subjects receiving neoadjuvant chemotherapy for advanced breast cancer will be asked to complete questionnaires, provide two blood samples, and provide 2 fecal samples while receiving standard of care neoadjuvant chemotherapy
  • Other: Blood & Fecal Collection
    Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package.

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Barbara Fuhrman, PhD
501-526-6684
bjfuhrman@uams.edu

More Details

NCT ID
NCT02696759
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Barbara Fuhrman, PhD.
501-526-6684
bjfuhrman@uams.edu

Detailed Description

Many chemotherapeutic agents compromise the integrity of the mucosal barrier in the gut, allowing translocation of gram-positive bacteria in secondary lymphoid organs. While this has, until recently, been considered an undesirable side-effect, it may also represent one mechanism by which chemotherapy stimulates an effective anti-cancer immune response. The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective. The hypothesis is that gut microbial composition can influence immune response to the tumor, resulting in inter-individual differences in the response to anti-cancer therapies.