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Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation

This study is currently recruiting participants.
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Michael Lock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01762020
First received: January 3, 2013
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.


Condition Intervention Phase
Breast Cancer
Dermatitis
 Device: 3M Cavilon No Sting Barrier Film
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women With Breast Cancer Receiving Adjuvant Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Percent of patients developing modified Radiation Therapy Oncology Group(RTOG) Visual Assessment Score Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer [ Time Frame: 3 1/2 - 5 weeks of radiation treatment. ] [ Designated as safety issue: No ]
    modified RTOG Visual Assessment Score


Secondary Outcome Measures:
  • Time to develop modified Radiation Therapy Oncology Group Visual Assessment Score Grade I, II, and/or Grade III radiation dermatitis [ Time Frame: 3 1/2 - 5 weeks of radiation treatment. ] [ Designated as safety issue: No ]
    Time will be measured in days

  • Absolute cost of barrier film and standard treatment care [ Time Frame: 3 1/2 - 5 weeks ] [ Designated as safety issue: No ]
    cost will be measured in Canadian dollars. The cost of standard care will be assessed by direct patient questioning on what was purchased. The cost of the Cavilon is standard for all patients (currently $28)


Estimated Enrollment: 47
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
3M Cavilon No Sting Barrier Film
Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.
 Device: 3M Cavilon No Sting Barrier Film
Half the breast will receive 3M Cavilon No Sting Barrier Film and one half will receive standard skin care
Other Name: Cavilon no-sting

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients between 18 and 80 years of age at the time of enrollment
  • Histopathologically or cytologically confirmed diagnosis of breast cancer
  • Completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection
  • Signed and dated ethics-approved informed consent form prior to any study procedures
  • Ability to comply with the requirements of the study
  • Scheduled adjuvant radiation therapy treatment

Exclusion Criteria:

  • Clinical or radiological evidence of local recurrence or metastatic disease
  • Previous history of radiation therapy to ipsilateral axilla and/or breast area
  • Planned boost of radiation Dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting
  • Any significant history or concurrent disease which, in the judgment of the Investigator would make the patient inappropriate for entry to this study
  • History of contraindications of radiation such as scleroderma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762020

Contacts
Contact: Michael Lock, MD, FRCPC 519-685-8650 michael.lock@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Principal Investigator: Michael Lock, MD,FRCPC            
Sponsors and Collaborators
Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Michael Lock, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01762020     History of Changes
Other Study ID Numbers: London Regional Cancer Program
Study First Received: January 3, 2013
Last Updated: January 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Women with Breast Cancer
Receiving Adjuvant Radiation Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013