Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Head and Neck Cancer

Treatments: Other: NeoVIDERM cream; Other: Aveeno cream; Other: Flamazine cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01701466

11-053

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Arm B: standard of care plus NeoVIDERM cream

Experimental group

Description:

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.

Treatment:

Other: NeoVIDERM cream

Other: Aveeno cream

Other: Flamazine cream

Arm A: standard skin care

Active Comparator group

Description:

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.

Treatment:

Other: Aveeno cream

Other: Flamazine cream