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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207324
• Other study ID #: R03-0030
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: June 26, 2007
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: June 2007
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 hypothesis is that silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• Silver Leaf Dressing

Locations

Country	Name	City	State
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy
Secondary	silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy