Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer
NCT ID: NCT01925651
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2013-08-31
2021-11-01
Brief Summary
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Detailed Description
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* 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 0.5cm bolus every other day or on consecutive days, and one lower risk group, which will be randomized to use bolus 0.5cm 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 kg/m2), 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Risk - No bolus
No Bolus
No Bolus
no bolus use
Standard Risk - Alternate Bolus
Alternate 5mm Bolus
Alternate Bolus
0.5cm bolus use in alternate days
High Risk - Alternate Bolus
Alternate 5mm Bolus
Alternate Bolus
0.5cm bolus use in alternate days
High Risk - Continuous bolus
Continuous 5mm bolus
Continuous Bolus
0.5 cm bolus use in continuous days
Interventions
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No Bolus
no bolus use
Alternate Bolus
0.5cm bolus use in alternate days
Continuous Bolus
0.5 cm bolus use in continuous days
Eligibility Criteria
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Inclusion Criteria
* breast malignancy histologically proven
Exclusion Criteria
* Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)
* Prior ipsilateral thoracic / cervical irradiation
* Proven metastatic disease (excluded from oncologic outcomes analyses)
18 Years
ALL
No
Sponsors
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AC Camargo Cancer Center
OTHER
Responsible Party
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Lucas Gomes Sapienza
Medical Doctor
Principal Investigators
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Lucas G Sapienza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AC Camargo Cancer Center
Locations
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AC Camargo Cancer Center
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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AC-B 01
Identifier Type: -
Identifier Source: org_study_id
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