Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The herbal products on reduction of radiation-induced dermatitis in patients with breast cancer

Detailed Description
-----------------
To compare the effect of each herb extracts to protect the skin from the adverse effects of radiation therapy in patients with breast cancer with herbal extract products.

Official Title
-----------------
Effects of Herbal Products on Reduction of Radiation-induced Dermatitis in Breast Cancer Patients

Conditions
-----------------
Radiodermatitis, Breast Neoplasms, Adverse Effect of Radiation Therapy

Intervention / Treatment
-----------------
* Other: Control
* Other: Cucumber cream
* Other: Centella cream
* Other: Thunbergia cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 20 years old or older, Diagnosed with Breast cancer On course of external Radiation therapy Exclusion Criteria: Pregnant Previously underwent external Radiation therapy Illiterate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard skin care<br>standard skin care | |
| Placebo Comparator: Control<br>Moisture Cream | Other: Control<br>* Apply moisture cream to the treatment skin everyday after radiation therapy<br>|
| Active Comparator: Cucumber cream<br>Apply Cucumber cream everyday after radiation therapy on the treatment aria skin. | Other: Cucumber cream<br>* Apply cucumber cream to the treatment skin everyday after radiation therapy<br>|
| Active Comparator: Centella cream<br>Apply Centella asiatica cream everyday after radiation therapy on the treatment aria skin. | Other: Centella cream<br>* Apply centella cream to the treatment skin everyday after radiation therapy<br>* Other names: Centella asiatica;|
| Active Comparator: Thunbergia cream<br>Apply Thunbergia cream everyday after radiation therapy on the treatment aria skin. | Other: Thunbergia cream<br>* Apply thunbergia cream to the treatment skin everyday after radiation therapy<br>* Other names: Thunbergia laurifolia Lindl;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of dermatitis grading | RTOG (Radiation Therapy Oncology Group) Cooperative Group Common Toxicity Criteria Skin Grade 0:None or no change Grade 1:Scattered macular or papular eruption or erythema that is asymptomatic Grade 2:Scattered macular or papular eruption or erythema with pruritis or other associated symptoms Grade 3:Generalized symptomatic macular, papular, or vesicular eruption Grade 4:Exfoliative dermatitis or ulcerating dermatitis Grade 5:If that toxicity caused the death of the patient. | Change from baseline dermatitis grading at 1, 2, 3, 4, 5 weeks and at 9 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the cream | Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied | At 9 week from date of randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herbal products, reduction of radiation-induced dermatitis, breast cancer, radiotherapy