Changes in GI Inflammation and the GI Microbiome Profile in Women With Breast Cancer Throughout Chemotherapy

Overview

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.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Komal Singh, Ph.D., R.N.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Komal Singh, Ph.D., R.N.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials