Breast NeoplasmsPhase 3NCT00207324
The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin Reactions
A Phase 3 study testing Silver Leaf Dressing in people with Breast Neoplasms, run by British Columbia Cancer Agency at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Silver Leaf Dressing
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Breast Neoplasms
- Being tested
- Silver Leaf Dressing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Leaf DressingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Investigators
- Christina Parsons, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207324
- Sponsor's protocol ID
- R03-0030
- Status last verified
- Jun 2007
- First submitted
- 15 Sep 2005
- Last updated
- 27 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00207324
- Acronym / sponsor ID
- R03-0030
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Jan 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Leaf Dressing | Device | – |
Primary outcome
silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy
1 secondary outcome
silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Parsons, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver Leaf Dressing in people with Breast Neoplasms, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2007.