Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: DCIS; Invasive Breast Cancer

Treatments: Other: Skin Swab Sample; Other: Stool sample

Study type: Observational

Funder types: Other

Identifiers

NCT04245150

CASE5118

Details and patient eligibility

About

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Full description

This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer patients with DCIS or invasive breast cancer
• Undergoing breast conserving surgery and adjuvant radiation
• Subjects must be willing and able to provide breast skin samples

Exclusion criteria

• Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
• Refuse or are unable to sign informed consent form
• Past history of breast cancer

Trial design

23 participants in 1 patient group

Ductal Carcinoma In Situ (DCIS) or invasive breast cancer

Description:

Participants with DCIS or invasive breast cancer

Treatment:

Other: Stool sample

Other: Skin Swab Sample