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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: Blood & Fecal Collection

• Registration Number: NCT02696759
• Lead Sponsor: University of Arkansas

Brief 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.

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.

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Study Start: 2016-07
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Results First Submitted: 2021-08-27
• Results First Submitted QC: 2021-08-27
• Results First Posted: 2021-09-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood & Fecal Collection	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

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Complete Fecal Collection	Through study completion, an average of 18 months	At least one fecal kit collected

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States