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

Mayo Clinic

Status: Terminated

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06238986

NCI-2024-00288 (Registry Identifier)

MC230407

23-007468 (Other Identifier)

Details and patient eligibility

About

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

9 participants in 1 patient group

Observational

Description:

Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.

Treatment:

Other: Non-Interventional Study