NCT06238986

Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2024-02-02
• Last updated: 2025-06-25

Locations

2 sites across 1 country: United States