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

NCT02696759 | Terminated Results

• 1 other identifier: 204897
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Complete Fecal Collection

  At least one fecal kit collected

  Through study completion, an average of 18 months

Study Arms (1)

Blood & Fecal Collection

OTHER

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

Interventions

Blood & Fecal Collection OTHER

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.

Blood & Fecal Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The secondary objectives were removed because it was decided (due to a number of parameters including the departure of the PI and failure to meet the enrollment goal) that the samples would not be analyzed. Thus, the secondary objectives in the previous submissions are no longer relevant, and there are no results to report.

Results Point of Contact

• Title: Beth Scanlan
• Organization: University of Arkansas for Medical Sciences

bscanlan@uams.edu

5016868274

Study Officials

• Issam Makhoul, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 2, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 16, 2022
• Results First Posted: September 24, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)