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Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

Primary Purpose

Head and Neck Cancer, Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aveeno cream
Flamazine cream
NeoVIDERM cream
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Patients, with

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm B: standard of care plus NeoVIDERM cream

Arm A: standard skin care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2012
Last Updated
May 22, 2015
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Avario Healthcare Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01701466
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Avario Healthcare Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Breast Cancer
Keywords
Patients, with

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm B: standard of care plus NeoVIDERM cream
Arm Type
Experimental
Arm 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.
Arm Title
Arm A: standard skin care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Aveeno cream
Intervention Description
Twice a day
Intervention Type
Other
Intervention Name(s)
Flamazine cream
Intervention Description
Twice a day, when there is dry desquamation
Intervention Type
Other
Intervention Name(s)
NeoVIDERM cream
Intervention Description
Three times a day
Primary Outcome Measure Information:
Title
Maximum skin toxicity
Description
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.
Time Frame
7 weeks post beginning of radiation treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te Vuong, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

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