Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether NeoVIDERM is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.

Official Title
-----------------
A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy

Conditions
-----------------
Head and Neck Cancer, Breast Cancer

Intervention / Treatment
-----------------
* Other: Aveeno cream
* Other: Flamazine cream
* Other: NeoVIDERM cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: For patients receiving radiation to the breast Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique. Patients able to understand and sign an informed consent form. Patients that do not have active connective tissue disorders. Patients 18 years or older. Patients that did not receive any previous radiation. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream Patients need to be able to apply the creams themselves or have help with applying the creams. Inclusion criteria: For patients receiving radiation to the head and neck Patients receiving radiotherapy on fields that include both sides of the neck Patients able to understand and sign an informed consent form. Patients that do not have active connective tissue disorders. Patients 18 years or older. Patients that did not receive any previous radiation. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream Patients need to be able to apply the creams themselves or have help with applying the creams. Exclusion criteria: For patients receiving radiation to the breast or the head and neck Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it). The Fitzpatrick Scale: Type I (scores 0-7) White; very fair; freckles. Always burns, never tans Type II (scores 8-16) White; fair. Usually burns, tans with difficulty Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease Type V (scores over 30) Dark brown. Very rarely burns, tans very easily Type VI Black. Never burns, tans very easily Allergic to any ingredient in Neoviderm cream

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm B: standard of care plus NeoVIDERM cream<br>Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment. | Other: Aveeno cream<br>* Twice a day<br>Other: Flamazine cream<br>* Twice a day, when there is dry desquamation<br>Other: NeoVIDERM cream<br>* Three times a day<br>|
| Active Comparator: Arm A: standard skin care<br>Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves. | Other: Aveeno cream<br>* Twice a day<br>Other: Flamazine cream<br>* Twice a day, when there is dry desquamation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum skin toxicity | The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care. | 7 weeks post beginning of radiation treatments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, with