Examining the link between gut microbiome changes and symptoms in women with breast cancer undergoing chemotherapy
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women with Breast Cancer Receiving Chemotherapy
This study is trying to see how changes in gut bacteria and inflammation affect the symptoms women with breast cancer experience while they are undergoing chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | trastuzumab, Chemotherapy, radiation, cyclophosphamide |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT06238986 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how alterations in the gastrointestinal (GI) microbiome and GI inflammation affect symptom burden in women diagnosed with breast cancer who are starting chemotherapy. The study aims to describe changes in GI inflammation and microbiome profiles throughout the chemotherapy process. It will also explore the relationship between these changes and the severity of neuropsychological and GI symptoms reported by patients at various time points. Participants will provide stool and blood samples, complete questionnaires, and have their medical records reviewed to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 or older with a new diagnosis of stage I-III breast cancer who are beginning their first cycle of chemotherapy.
Not a fit: Patients with metastatic disease, cognitive impairments, or significant GI co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of symptoms in women with breast cancer undergoing chemotherapy by understanding the role of the gut microbiome.
How similar studies have performed: Other studies have shown promising results in understanding the relationship between the microbiome and various health conditions, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Komal P. Singh, PhD, RN — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.