Clinical trial NCT01701466: Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Breast Cancer
Keywords: Patients
with
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Avario Healthcare Inc.
First posted: 2012-10-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion criteria: For patients receiving radiation to the breast

1. Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique.
2. Patients able to understand and sign an informed consent form.
3. Patients that do not have active connective tissue disorders.
4. Patients 18 years or older.
5. Patients that did not receive any previous radiation.
6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
7. 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

1. Patients receiving radiotherapy on fields that include both sides of the neck
2. Patients able to understand and sign an informed consent form.
3. Patients that do not have active connective tissue disorders.
4. Patients 18 years or older.
5. Patients that did not receive any previous radiation.
6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
7. 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

1. 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
2. Allergic to any ingredient in Neoviderm cream

Primary outcomes:
measure: Maximum skin toxicity
timeFrame: 7 weeks post beginning of radiation treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Te Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References: