Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Conditions
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DCIS, Invasive Breast Cancer

Intervention / Treatment
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* Other: Stool sample
* Other: Skin Swab Sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ductal Carcinoma In Situ (DCIS) or invasive breast cancer<br>Participants with DCIS or invasive breast cancer | Other: Stool sample<br>* Stool sample<br>Other: Skin Swab Sample<br>* Skin Swab Sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome profile as assessed by stool sample | Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample | At baseline | 
| Microbiome profile as assessed by breast skin sample | Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample | At baseline | 
| Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring | The microbiome profiles identified will be correlated with incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring by visual assessment. Maximum toxicity during radiation will be recorded. Grade 0: None Grade 1: Faint erythema or dry desquamation Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated | 3 months post-treatment |