Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women with Breast Cancer Receiving Chemotherapy
- Conditions
- Anatomic Stage I Breast Cancer AJCC V8Anatomic Stage II Breast Cancer AJCC V8Anatomic Stage III Breast Cancer AJCC V8
- Interventions
- Other: Non-Interventional Study
- Registration Number
- NCT06238986
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Non-Interventional Study Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
- Primary Outcome Measures
Name Time Method 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.
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.
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 - 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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (2)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States