Anatomic Stage I Breast Cancer AJCC v8NCT06238986
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Non-Interventional Study
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2024to 18 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with newly diagnosed stage I-III breast cancer recruited from the outpatient breast cancer clinic at University of Iowa Hospital and Clinics and at Mayo Clinic in Rochester and Mayo Clinic in Arizona.
Who may be able to join
- Female with a new diagnosis of breast cancer (stage I-III)
- Age 20 or older
- Able to read and write in English
- Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive
Who cannot join
- Metastatic disease
- Cognitive impairment, based on clinician assessment, that would prevent completing measures
- Concurrent radiation therapy or radiation therapy within the last three months
- GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months
- A stoma preventing stool collection from the large intestine (i.e., ileostomy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy.
II. To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
III. To examine associations between microbial composition functional profiles at T1 and T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints.
IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2, T3 and T4.
OUTLINE: This is an observational study.
Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GI microbiome profile
To examine longitudinal change in the GI microbiome, the coefficient of variation (CV) of alpha-diversity values will be calculated for stool samples. The CV represents the ratio of the standard deviation to the mean. A low CV indicates that an individual has relatively stable microbial diversity over time and a high CV indicates that an individual has higher microbial diversity over time.
Measured: Up to 1 month after chemotherapy treatment completion
Change in GI inflammation
GI Inflammation will be quantified through measures of fecal calprotectin to indicate low, medium and high concentrations of bowel inflammation.
Measured: Up to 1 month after chemotherapy treatment completion
Symptom burden - MSAS
Symptom burden will be measured with a modified version of the Memorial Symptom Assessment Scale (MSAS). The modified MSAS includes 41 symptom items, including 19 GI symptoms. Participants are asked to review the list of symptoms and indicate which had been present in the last week. For each symptom present, participants are asked to rate its duration, severity, and distress.
Measured: Up to 1 month after chemotherapy treatment completion
Symptom burden - MASCC-MAT
Symptom burden will be measured with the Multinational Association of Supportive Care in Cancer-Antiemesis Tool (MASCC-MAT). The MASCC-MAT assesses acute (i.e., within 24 hours post-chemotherapy) and delayed (i.e., after 24 hours and up to 7 days post-chemotherapy) occurrence of chemotherapy-induced nausea (CIN).
Measured: Up to 1 month after chemotherapy treatment completion
Symptom burden - LFS
Symptom burden will be measured with the Lee Fatigue Scale (LFS). The LFS consists of 18 items related to fatigue and energy. Scores range from 0-180 with higher scores indicating higher levels of fatigue.
Measured: Up to 1 month after chemotherapy treatment completion
Secondary outcomes (2)
Associations between microbial composition functional profiles and symptom severity
In patients who report symptom severity in neuropsychological and GI symptoms for at least three timepoints, stool samples will be tested to find distinct diversity and abundance changes between timepoints that are associated with symptom occurrence.
Measured: Up to 1 month after chemotherapy treatment completion
Change in metabolite abundance
In patients who do and do not report neuropsychological and GI symptom occurrence for at least three timepoints, stool samples and blood samples will be evaluated using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to evaluate for change in metabolite abundance and associations between bacterial composition and metabolic profiles.
Measured: Up to 1 month after chemotherapy treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start22 Mar 2024
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Komal P. Singh, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238986
- Sponsor's protocol ID
- MC230407
- Other IDs
- NCI-2024-00288, 23-007468
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06238986
- Acronym / sponsor ID
- MC230407
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy.
II. To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
III. To examine associations between microbial composition functional profiles at T1 and T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints.
IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2, T3 and T4.
OUTLINE: This is an observational study.
Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with newly diagnosed stage I-III breast cancer recruited from the outpatient breast cancer clinic at University of Iowa Hospital and Clinics and at Mayo Clinic in Rochester and Mayo Clinic in Arizona.
Key inclusion criteria (4 listed)
- Female with a new diagnosis of breast cancer (stage I-III)
- Age 20 or older
- Able to read and write in English
- Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive
Key exclusion criteria (5 listed)
- Metastatic disease
- Cognitive impairment, based on clinician assessment, that would prevent completing measures
- Concurrent radiation therapy or radiation therapy within the last three months
- GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months
- A stoma preventing stool collection from the large intestine (i.e., ileostomy)
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Change in GI microbiome profile
Time frame: Up to 1 month after chemotherapy treatment completion
To examine longitudinal change in the GI microbiome, the coefficient of variation (CV) of alpha-diversity values will be calculated for stool samples. The CV represents the ratio of the standard deviation to the mean. A low CV indicates that an individual has relatively stable microbial diversity over time and a high CV indicates that an individual has higher microbial diversity over time.
Change in GI inflammation
Time frame: Up to 1 month after chemotherapy treatment completion
GI Inflammation will be quantified through measures of fecal calprotectin to indicate low, medium and high concentrations of bowel inflammation.
Symptom burden - MSAS
Time frame: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with a modified version of the Memorial Symptom Assessment Scale (MSAS). The modified MSAS includes 41 symptom items, including 19 GI symptoms. Participants are asked to review the list of symptoms and indicate which had been present in the last week. For each symptom present, participants are asked to rate its duration, severity, and distress.
Symptom burden - MASCC-MAT
Time frame: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with the Multinational Association of Supportive Care in Cancer-Antiemesis Tool (MASCC-MAT). The MASCC-MAT assesses acute (i.e., within 24 hours post-chemotherapy) and delayed (i.e., after 24 hours and up to 7 days post-chemotherapy) occurrence of chemotherapy-induced nausea (CIN).
Symptom burden - LFS
Time frame: Up to 1 month after chemotherapy treatment completion
Symptom burden will be measured with the Lee Fatigue Scale (LFS). The LFS consists of 18 items related to fatigue and energy. Scores range from 0-180 with higher scores indicating higher levels of fatigue.
2 secondary outcomes
Associations between microbial composition functional profiles and symptom severity
Time frame: Up to 1 month after chemotherapy treatment completion
Change in metabolite abundance
Time frame: Up to 1 month after chemotherapy treatment completion
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Komal P. Singh, PhD, RN principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 2 sites 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 4 inclusion and 5 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Change in GI microbiome profile (time frame: Up to 1 month after chemotherapy treatment completion). The study lists 5 primary outcomes in all. 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 25 Jun 2025.