Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01925651
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2013-08-15
Brief Title:
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-07
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 aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy in relation to the time of treatment interruption and acute effects This study evaluates whether there is an increase in treatment time with the addition of the bolus which can overshadow the benefit of increased dose to the skin and subcutaneous tissue The patients will continue to be followed for oncologic outcomes focusing on chest wall local control
Detailed Description:
Rational
The use of high-energy photons 6 MeV creates a characteristic skin-sparing effect which can generate a region of low-dose subcutaneous tissue
The subcutaneous tissue is a possible area of clinical failure in the chest wall after mastectomy for breast cancer
To optimize treatment it is used a bio-equivalent material to increase the surface dose
This dose increase may be accompanied by greater skin reaction making it necessary to temporarily discontinue treatment to recover radiodermatitis
The total treatment time is a determinant of tumor control in the treatment of cancer with radiation
Description
This study aims to evaluate whether different intensities of application of the bolus correlate with greater likelihood of treatment discontinuation
This will be a single blind randomised controlled trial The target population comprises patients with indication of post mastectomy radiation PMRT
The patients will be divided into two groups one with higher risk of recurrence in subcutaneous which will be randomized to use 05cm bolus every other day or on consecutive days and one lower risk group which will be randomized to use bolus 05cm on alternate days or do not use bolus The group with high risk is defined as patients with clinical or pathological tumor invasion of skin The others will be considered standard risk
Randomization will be made so that each group has the same proportion of patients with high body mass index 30 kgm2 as this may be a factor in worsening radiodermatitis
The patients will be followed during treatment and will be evaluated weekly for the radiodermatitis interruption time of treatment for recovery from the acute effects and expenditures for local care The evaluation will be done blindly without knowledge of the utilization of bolus by trained nurses in the management of radiodermatitis After treatment patients will continue to be followed for oncologic outcomes focusing on chest wall local control
The use of high-energy photons 6 MeV creates a characteristic skin-sparing effect which can generate a region of low-dose subcutaneous tissue
The subcutaneous tissue is a possible area of clinical failure in the chest wall after mastectomy for breast cancer
To optimize treatment it is used a bio-equivalent material to increase the surface dose
This dose increase may be accompanied by greater skin reaction making it necessary to temporarily discontinue treatment to recover radiodermatitis
The total treatment time is a determinant of tumor control in the treatment of cancer with radiation
Description
This study aims to evaluate whether different intensities of application of the bolus correlate with greater likelihood of treatment discontinuation
This will be a single blind randomised controlled trial The target population comprises patients with indication of post mastectomy radiation PMRT
The patients will be divided into two groups one with higher risk of recurrence in subcutaneous which will be randomized to use 05cm bolus every other day or on consecutive days and one lower risk group which will be randomized to use bolus 05cm on alternate days or do not use bolus The group with high risk is defined as patients with clinical or pathological tumor invasion of skin The others will be considered standard risk
Randomization will be made so that each group has the same proportion of patients with high body mass index 30 kgm2 as this may be a factor in worsening radiodermatitis
The patients will be followed during treatment and will be evaluated weekly for the radiodermatitis interruption time of treatment for recovery from the acute effects and expenditures for local care The evaluation will be done blindly without knowledge of the utilization of bolus by trained nurses in the management of radiodermatitis After treatment patients will continue to be followed for oncologic outcomes focusing on chest wall local control
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