Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GI inflammation | 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 - MASCC-MAT | 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 | 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. |
| Change in GI microbiome profile | 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. |
| Symptom burden - MSAS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolite abundance | Up to 1 month after chemotherapy treatment completion | 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. |
| Associations between microbial composition functional profiles and symptom severity | Up to 1 month after chemotherapy treatment completion | 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. |
Countries
United States
Outcome results
None listed