NCT01701466

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

October 3, 2012

Last Update Submit

May 22, 2015

Conditions

Head and Neck CancerBreast Cancer

Keywords

Patientswith

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 weeks post beginning of radiation treatments

Study Arms (2)

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.

Other: Aveeno creamOther: Flamazine creamOther: 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.

Other: Aveeno creamOther: Flamazine cream

Interventions

Aveeno creamOTHER

Twice a day

Arm A: standard skin careArm B: standard of care plus NeoVIDERM cream
Flamazine creamOTHER

Twice a day, when there is dry desquamation

Arm A: standard skin careArm B: standard of care plus NeoVIDERM cream
NeoVIDERM creamOTHER

Three times a day

Arm B: standard of care plus NeoVIDERM cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Te Vuong, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Radiation-oncology department

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2014

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

CA(1)