Loading clinical trials...

Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis | Clinical Trials | Clareo Health

UNKNOWN

Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis

Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis

NCT04268056•AceTech

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Histological confirmation of breast malignancy
•3. Primary or recurrent disease eligible
•4. Patients after breast lumpectomy and that scheduled to receive radiotherapy
•5. Patients that receive minimum of 45 Gy
•6. Ability to complete questionnaire(s) by themselves or with assistance
•7. Provide informed written consent

Exclusion Criteria

•1. Patients with prior radiotherapy to any portion of the planned treatment site
•2. Tumour involvement of the skin
•3. Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
•4. Patient with other skin diseases/ skin disorders
•5. Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
•6. Recent use of any of the following within 21 days of first swab collection: o Systemic or topical steroids o Use of systemic immunosuppressant drugs o Use of ultraviolet light therapy
•7. Prior usage of other topical and systemic medications within 21 days of first swab collection
•8. Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
•9. Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
•10. Prior organ or bone marrow transplant
+1 more criteria

Locations (1)

Rambam Medical Center

Haifa, Israel

Key Dates

Start Date

November 1, 2020

Primary Completion Date

July 20, 2021

Completion Date

November 1, 2021

Last Updated

July 21, 2021

Enrollment

100

ACTUAL participants

Conditions

Radiation Dermatitis

Interventions

Collection of skin culture samples

DIAGNOSTIC_TEST

ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

NCT07081074

Radiation Dermatitis

View study

RECRUITINGNA

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

NCT03394417

Head and Neck CancersAcute Radiation Dermatitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis

Inclusion Criteria

Exclusion Criteria

ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer

Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients

Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis