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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Lock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01762020
First received: January 3, 2013
Last updated: March 6, 2017
Last verified: March 2017
  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 Drug: Standard Preparation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
within patient randomization of Cavilon skin spray
Masking: Care Provider
Masking Description:
within patient randomization. One half of breast received Cavilon and other receives standard of care treatment. Care provider is blinded as to portion receiving treatment.
Primary Purpose: Treatment
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:


Further study details as provided by Michael Lock, 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. ]
    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. ]
    Time will be measured in days

  • Absolute cost of barrier film and standard treatment care [ Time Frame: 3 1/2 - 5 weeks ]
    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)


Enrollment: 56
Study Start Date: January 2013
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Placebo Comparator: Standard preparations
Standard treatment
Drug: Standard Preparation
standard creams
Other Name: standard creams

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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: NCT01762020

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

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: March 6, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Release as requested and via publication access notification

Keywords provided by Michael Lock, 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 June 22, 2017