Breast CancerNCT02696759
Gut Microbiome & Gastrointestinal Toxicities as Determinants of Response to Neoadjuvant Chemo for Advanced Breast Cancer
A study testing Blood & Fecal Collection in people with Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood & Fecal Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with invasive breast cancer and prescribed a regimen that includes neo-adjuvant therapy prior to breast surgery.
- Able to provide informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: The Gut Microbiome and Gastrointestinal Toxicities as Determinants of the Response to Neoadjuvant Chemotherapies for Advanced Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Blood & Fecal Collection
- Keywords
- Breast, Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood & Fecal CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood & Fecal Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Complete Fecal Collection
At least one fecal kit collected
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2021
- Study completionAug 2021
Why it stopped: PI left institution in 2019. Study was placed on hold at that time and will not be resuming. No data analysis was performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issam Makhoul, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696759
- Sponsor's protocol ID
- 204897
- Status last verified
- Jan 2022
- First submitted
- 4 Feb 2016
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data can be shared internally at the University of Arkansas for Medical Sciences (UAMS) or in an National Institutes of Health (NIH)-designated data repository in a manner consistent with all applicable federal and state laws. Subjects who agree to participate in this study, will be given the option to have their data shared; however, opting not to participate in data sharing will have no impact on their study participation.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiome and Gastrointestinal Toxicities as Determinants of the Response to Neoadjuvant Chemotherapies for Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02696759
- Acronym / sponsor ID
- 204897
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution in 2019. Study was placed on hold at that time and will not be resuming. No data analysis was performed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood & Fecal Collection | Other | Other: Blood & Fecal CollectionSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with invasive breast cancer and prescribed a regimen that includes neo-adjuvant therapy prior to breast surgery.
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood & Fecal CollectionPrior 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. | Other | Blood & Fecal Collection |
Primary outcome
Number of Subjects Who Complete Fecal Collection
Time frame: Through study completion, an average of 18 months
At least one fecal kit collected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data can be shared internally at the University of Arkansas for Medical Sciences (UAMS) or in an National Institutes of Health (NIH)-designated data repository in a manner consistent with all applicable federal and state laws. Subjects who agree to participate in this study, will be given the option to have their data shared; however, opting not to participate in data sharing will have no impact on their study participation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Makhoul, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood & Fecal Collection in people with Breast Cancer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Complete Fecal Collection (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.