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

University of Arkansas logo

University of Arkansas

Status

Terminated

Conditions

Breast Cancer

Treatments

Other: Blood & Fecal Collection

Study type

Interventional

Funder types

Other

Identifiers

NCT02696759
204897

Details and patient eligibility

About

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.

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.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Blood & Fecal Collection
Other group
Description:
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
Treatment:
Other: Blood & Fecal Collection

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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