Changes in GI Inflammation and the GI Microbiome Profile in Women With Breast Cancer Throughout Chemotherapy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-007468
- Scottsdale/Phoenix, Arizona: 23-007468
NCT ID: NCT06238986
Sponsor Protocol Number: MC230407
About this study
The purpose of this study is to describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy. Also, to examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 naïve and beginning the first cycle of moderately or highly emetogenic chemotherapy (Taxotere + Cyclophosphamide treatment +/- Trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naïve.
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).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/9/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Kathryn Ruddy, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Komal Singh, Ph.D., R.N. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available