Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT02696759

Recruitment Status:

Terminated

Sponsor:

University of Arkansas

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There is 1 Location for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

15

Study ID:

NCT02696759

Recruitment Status:

Terminated

Sponsor:


University of Arkansas

How clear is this clinincal trial information?

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