Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis - Full Text View

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:

Genetics Home Reference related topics: breast cancer

Drug Information available for: Sulfadiazine, silver

U.S. FDA Resources

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.


Enrollment:	14
Study Start Date:	December 2011
Primary Completion Date:	May 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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701466

Locations


Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2

Sponsors and Collaborators

Sir Mortimer B. Davis - Jewish General Hospital

Avario Healthcare Inc.

Investigators


Principal Investigator:	Te Vuong, MD	Jewish General Hospital

More Information


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:	May 22, 2015
Health Authority:	Canada: Research Ethics Office

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


Patients with

Additional relevant MeSH terms:


Head and Neck Neoplasms Dermatitis Radiodermatitis Neoplasms by Site Neoplasms Skin Diseases	Radiation Injuries Wounds and Injuries Silver Sulfadiazine Anti-Infective Agents, Local Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016