Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
This study is currently recruiting participants.
Verified May 2013 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
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: May 7, 2013
Last verified: May 2013
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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.
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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
- 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
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: | May 7, 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 May 22, 2013