Clinical trial NCT06238986: Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
Official title: Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in GI microbiome profile
timeFrame: Up to 1 month after chemotherapy treatment completion
measure: Change in GI inflammation
timeFrame: Up to 1 month after chemotherapy treatment completion
measure: Symptom burden - MSAS
timeFrame: Up to 1 month after chemotherapy treatment completion
measure: Symptom burden - MASCC-MAT
timeFrame: Up to 1 month after chemotherapy treatment completion
measure: Symptom burden - LFS
timeFrame: Up to 1 month after chemotherapy treatment completion
Secondary outcomes:
measure: Associations between microbial composition functional profiles and symptom severity
timeFrame: Up to 1 month after chemotherapy treatment completion
measure: Change in metabolite abundance
timeFrame: Up to 1 month after chemotherapy treatment completion
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Komal P. Singh, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: