Radiation Dermatitis
Conditions
Keywords
Radiation dermatitis, Radio Therapy, Microbiome Profile
Brief 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.
Interventions
DIAGNOSTIC_TESTCollection 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.
Sponsors
AceTech
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dermatitis grade | through study completion, an average of 1 year | 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. |
| Microbiome composition | through study completion, an average of 1 year | Collection of skin culture samples from body regions surrounding the RT treatment area and a control area |
Secondary
| 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 |
Countries
Israel
Outcome results
None listed