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

NCT00207324 | Completed Phase 3

• 1 other identifier: R03-0030
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Silver Leaf Dressing DEVICE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christina Parsons, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2004
• Study Completion: January 1, 2007
• Last Updated: June 27, 2007

Record last verified: 2007-06

Locations

CA (1)