Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Invasive Breast Cancer Clinical Trial

Official title:

Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04245150
• Other study ID #: CASE5118
• Status: Active, not recruiting
• Start date: March 21, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• DCIS
• Invasive Breast Cancer

Intervention

Other:
• Stool sample
Stool sample
• Skin Swab Sample
Skin Swab Sample

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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