Status:
COMPLETED
The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin Reactions
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Canadian Breast Cancer Foundation
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
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 hypothes...
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 ...
Eligibility Criteria
Inclusion
- 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).
- Patients undergoing nodal radiotherapy are eligible if criterion 1 is met
- 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
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00207324
Start Date
January 1 2004
End Date
January 1 2007
Last Update
June 27 2007
Active Locations (1)
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1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6