Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207324
Status:
COMPLETED
Last Update Posted:
2007-06-27
First Post:
2005-09-15
Brief Title:
The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin Reactions
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None