Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer

July 18, 2022 updated by: Lucas Gomes Sapienza, AC Camargo Cancer Center

Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01509-010
        • AC Camargo Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing mastectomy with or without reconstruction of early breast
  • breast malignancy histologically proven
  • protocol addended to allow inclusion of men that meet all inclusion criteria

Exclusion Criteria:

  • Karnofsky Performance Scale (KPS) <70%
  • Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)
  • Prior ipsilateral thoracic / cervical irradiation
  • Proven metastatic disease (excluded from oncologic outcomes analyses)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Risk - No bolus
No Bolus
Radiation: No Bolus
no bolus use
Other: Standard Risk - Alternate Bolus
Alternate 5mm Bolus
Radiation: Alternate Bolus
0.5cm bolus use in alternate days
Other: High Risk - Alternate Bolus
Alternate 5mm Bolus
Radiation: Alternate Bolus
0.5cm bolus use in alternate days
Other: High Risk - Continuous bolus
Continuous 5mm bolus
Radiation: Continuous Bolus
0.5 cm bolus use in continuous days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute radiodermatitis
Time Frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0
participants will be followed for the duration of radiotherapy, an expected average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interruption Time
Time Frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Treatment Interruption time due to radiodermatitis
participants will be followed for the duration of radiotherapy, an expected average of 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Care Costs
Time Frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Local Care Costs with radiodermatitis
participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Local Control
Time Frame: From date of randomization until the date of first documented local progression in the chest wall or date of death from any cause, whichever came first, assessed up to 100 months
local control in the chest wall assessed by physical examination and complementary exams.
From date of randomization until the date of first documented local progression in the chest wall or date of death from any cause, whichever came first, assessed up to 100 months
Metastasis-Free Interval
Time Frame: From date of randomization until the date of first documented distant progression or date of death from any cause, whichever came first, assessed up to 100 months
Metastasis-Free Interval (following departmental post-treatment surveillance visits routine).
From date of randomization until the date of first documented distant progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (following departmental post-treatment surveillance visits routine).
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Investigators

  • Principal Investigator: Lucas G Sapienza, MD, PhD, AC Camargo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-B 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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