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The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin Reactions

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00207324
First received: September 15, 2005
Last updated: June 26, 2007
Last verified: June 2007
  Purpose

The hypothesis is that silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy. The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy.


Condition Intervention Phase
Breast Neoplasms
Device: Silver Leaf Dressing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: A Phase III Study of the Efficacy of Silver Leaf Nylon Dressing in the Prevention of Severe Skin Reactions in the Inframammary Skin Fold of Patients Receiving Adjuvant Whole Breast Radiotherapy

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy

Secondary Outcome Measures:
  • silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy

Estimated Enrollment: 100
Study Start Date: January 2004
Study Completion Date: January 2007
Detailed Description:

Purpose: The delivery of whole breast radiotherapy to women with a deep inframammary fold frequently results in a marked skin reaction (brisk erythema and/or moist desquamation). The main aim of this study is to compare the efficacy of prophylactic silver leaf nylon dressings with standard skin care against standard skin care alone in the prevention of brisk erythema and moist desquamation. A secondary aim of the study is to assess whether the use of silver leaf nylon dressings can reduce breast-related symptoms of pain, burning sensation and itching in women undergoing whole breast radiotherapy.

Hypothesis: The hypothesis is that silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy. The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy. The null hypotheses are that there is no reduction in brisk erythema, moist desquamation or breast-related symptoms in patients undergoing whole breast radiotherapy with the use of silver leaf nylon dressing.

Justification: Severe skin reactions are common in patients with a deep inframammary fold who undergo whole breast radiotherapy. It may be possible to reduce the severity of skin reactions in this population of patients with the use of silver leaf nylon dressing. This might make whole breast radiotherapy more tolerable for patients.

Objectives: The objectives of this study are to compare the severity of skin reactions of patients with a deep inframammary skin fold undergoing whole breast radiotherapy (using the Radiation Therapy Oncology Group scoring system, as well as a supplementary scoring system) between the experimental arm and the control arm, and to compare the severity of breast- related symptoms (using visual analogue scales), topical steroid use and analgesic use between the two study arms.

Research Method: This will be a single blind randomised controlled trial. The target population comprises patients with a deep inframammary fold undergoing whole breast radiotherapy. Patients will be randomised to follow standard skin care recommendations throughout radiotherapy treatment (control arm) or to follow these recommendations in addition to using a silver leaf nylon dressing (experimental arm). Randomisation will be stratified for the delivery of prior chemotherapy and for the radiotherapy fractionation schedule (extended versus standard).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women diagnosed with completely excised stage I or II invasive breast cancer, or DCIS, who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy will be eligible for this study if they are at increased risk of radiodermatitis at the inframammary fold due to breast size or shape (i.e at least 2cm of skin apposition at the inframammary fold, and/or brassiere cup size C or greater).
  2. Patients undergoing nodal radiotherapy are eligible if criterion 1 is met
  3. Patients undergoing boost radiotherapy are eligible if criterion 1 is met, but only if the boost volume does not include any part of the breast inferior to the nipple line
  4. Patients may be entered into other local or national trials unless these involve an alteration to standard skin care or altered breast radiotherapy technique

Exclusion Criteria:

  • inability to give informed consent
  • inability to comply with experimental arm of trial
  • failure of healing of the surgical scar or significant post-operative infection of the wound
  • prior radiotherapy to either breast or to the chest
  • presence of significant connective tissue disease (e.g. systemic sclerosis, systemic lupus erythematosis)
  • known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc)
  • inability to return for assessment at one week following completion of radiotherapy
  • allergy to silver
  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: NCT00207324

Locations
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Christina Parsons, MD British Columbia Cancer Agency
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00207324     History of Changes
Other Study ID Numbers: R03-0030
Study First Received: September 15, 2005
Last Updated: June 26, 2007
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 20, 2014