Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01701466
• Other study ID #: 11-053
• Status: Terminated
• Phase: Phase 2
• First received: October 3, 2012
• Last updated: May 22, 2015
• Start date: December 2011

Study information

• Verified date: May 2015
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Office
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01470872

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

Other:
• Aveeno cream
Twice a day
• Flamazine cream
Twice a day, when there is dry desquamation
• NeoVIDERM cream
Three times a day

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital	Avario Healthcare Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes