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
N/A
N/A
Female
Breast Neoplasms
Trial Information
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
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
Outcome Measure:
silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy
Principal Investigator
Christina Parsons, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
Canada: Health Canada
Study ID:
R03-0030
NCT ID:
NCT00207324
Start Date:
January 2004
Completion Date:
January 2007
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|
