Head and Neck CancerPhase 2NCT01701466
Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
A Phase 2 study testing Aveeno cream, Flamazine cream and NeoVIDERM cream in people with Head and Neck Cancer and Breast Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Breast Cancer
- What is being tested?
- Aveeno cream, Flamazine cream and NeoVIDERM cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Head and Neck Cancer, Breast Cancer
- Being tested
- Aveeno cream, Flamazine cream, NeoVIDERM cream
- Keywords
- Patients, with
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aveeno creamOther
Twice a day
Flamazine creamOther
Twice a day, when there is dry desquamation
NeoVIDERM creamOther
Three times a day
| Study group | Role | What they receive |
|---|---|---|
| Arm B: standard of care plus NeoVIDERM cream | Experimental | 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. Receives: Other: Aveeno cream; Other: Flamazine cream; Other: NeoVIDERM cream |
| Arm A: standard skin care | Active comparator | 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. Receives: Other: Aveeno cream; Other: Flamazine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks post beginning of radiation treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Avario Healthcare Inc.
- Responsible party
- Principal investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701466
- Sponsor's protocol ID
- 11-053
- Status last verified
- May 2015
- First submitted
- 3 Oct 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01701466
- Acronym / sponsor ID
- 11-053
- Conditions
- Head and Neck Cancer, Breast Cancer
- Keywords
- Patients, with
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Avario Healthcare Inc.
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B: standard of care plus NeoVIDERM cream | Experimental | Other: Aveeno cream, Other: Flamazine cream, Other: NeoVIDERM creamPatients 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 A: standard skin care | Active comparator | Other: Aveeno cream, Other: Flamazine creamPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aveeno creamTwice a day | Other | Arm A: standard skin care, Arm B: standard of care plus NeoVIDERM cream |
| Flamazine creamTwice a day, when there is dry desquamation | Other | Arm A: standard skin care, Arm B: standard of care plus NeoVIDERM cream |
| NeoVIDERM creamThree times a day | Other | Arm B: standard of care plus NeoVIDERM cream |
Primary outcome
Maximum skin toxicity
Time frame: 7 weeks post beginning of radiation treatments
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Te Vuong, MD principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aveeno cream, Flamazine cream and NeoVIDERM cream in people with Head and Neck Cancer and Breast Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum skin toxicity (time frame: 7 weeks post beginning of radiation treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.