Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

This study is currently recruiting participants.
Verified September 2013 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Collaborator:
Avario Healthcare Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01701466
First received: October 3, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Breast Cancer
Other: Aveeno cream
Other: Flamazine cream
Other: NeoVIDERM cream
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm B: standard of care plus NeoVIDERM cream
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
Twice a day
Other: Flamazine cream
Twice a day, when there is dry desquamation
Other: NeoVIDERM cream
Three times a day
Active Comparator: Arm A: standard skin care
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
Twice a day
Other: Flamazine cream
Twice a day, when there is dry desquamation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701466

Contacts
Contact: Chantal Cadieux, PhD 1-514-340-8222 ext 6199 ccadieux@jgh.mcgillca

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Chantal Cadieux, PhD    514-340-8222 ext 6199    ccadieux@jgh.mcgill.ca   
Principal Investigator: Te Vuong, MD         
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Avario Healthcare Inc.
Investigators
Principal Investigator: Te Vuong, MD Jewish General Hospital
  More Information

No publications provided

Responsible Party: Dr. Te Vuong, Director Radiation-oncology department, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01701466     History of Changes
Obsolete Identifiers: NCT01470872
Other Study ID Numbers: 11-053
Study First Received: October 3, 2012
Last Updated: September 26, 2013
Health Authority: Canada: Research Ethics Office

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
Patients
with

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Head and Neck Neoplasms
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014