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NCT Number: NCT04245150

Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

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.

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Key information

Conditions

DCIS Adenocarcinoma Breast Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Invasive Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sample

Other

Stool sample

Skin Swab Sample

Other

Skin Swab Sample

Primary outcomes

  1. Microbiome profile as assessed by stool sample

    Time frame: At baseline

    Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  2. Microbiome profile as assessed by breast skin sample

    Time frame: At baseline

    Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  3. Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring

    Time frame: 3 months post-treatment

    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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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