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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Diagnostic test: Collection of skin culture samples

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer undergoing radiation therapy.

Description

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
11. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RT patients; 100 patients with breast cancer undergoing radiation therapy	Diagnostic test: Collection of skin culture samples; Collection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dermatitis grade	Study participant will be evaluated by physician and nurse for the occurrence and the severity of RD. Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring.	through study completion, an average of 1 year
Microbiome composition	Collection of skin culture samples from body regions surrounding the RT treatment area and a control area	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: AceTech
• Investigators: Principal Investigator: Roxolyana Abdah-Borthnyak, MD, Director, Radiation Service for Female Cancer

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): July 20, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Radiation dermatitis; Radio Therapy; Microbiome Profile
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: 0141-19-RMB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No