Breast CancerNCT01925651
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer
A study testing No Bolus, Alternate Bolus and Continuous Bolus in people with Breast Cancer and Radiodermatitis, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiodermatitis
- What is being tested?
- No Bolus, Alternate Bolus and Continuous Bolus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to 1 Nov 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Radiodermatitis
- Being tested
- No Bolus, Alternate Bolus, Continuous Bolus
- Keywords
- Post Mastectomy Radiotherapy, Breast Cancer, Bolus, Radiodermatitis
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No BolusRadiation
no bolus use
Alternate BolusRadiation
0.5cm bolus use in alternate days
Continuous BolusRadiation
0.5 cm bolus use in continuous days
| Study group | Role | What they receive |
|---|---|---|
| Standard Risk - No bolus | Other | No Bolus Receives: Radiation: No Bolus |
| Standard Risk - Alternate Bolus | Other | Alternate 5mm Bolus Receives: Radiation: Alternate Bolus |
| High Risk - Alternate Bolus | Other | Alternate 5mm Bolus Receives: Radiation: Alternate Bolus |
| High Risk - Continuous bolus | Other | Continuous 5mm bolus Receives: Radiation: Continuous Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute radiodermatitis
Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0
Measured: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Secondary outcomes (1)
Interruption Time
Treatment Interruption time due to radiodermatitis
Measured: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Gomes Sapienza, AC Camargo Cancer Center
- Investigators
- Lucas G Sapienza, MD, PhD, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925651
- Sponsor's protocol ID
- AC-B 01
- Status last verified
- Jul 2022
- First submitted
- 15 Aug 2013
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01925651
- Acronym / sponsor ID
- AC-B 01
- Conditions
- Breast Cancer, Radiodermatitis
- Keywords
- Post Mastectomy Radiotherapy, Breast Cancer, Bolus, Radiodermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 20 Aug 2013 (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 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Risk - No bolus | Other | Radiation: No BolusNo Bolus |
| Standard Risk - Alternate Bolus | Other | Radiation: Alternate BolusAlternate 5mm Bolus |
| High Risk - Alternate Bolus | Other | Radiation: Alternate BolusAlternate 5mm Bolus |
| High Risk - Continuous bolus | Other | Radiation: Continuous BolusContinuous 5mm bolus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| No Bolusno bolus use | Radiation | Standard Risk - No bolus |
| Alternate Bolus0.5cm bolus use in alternate days | Radiation | High Risk - Alternate Bolus, Standard Risk - Alternate Bolus |
| Continuous Bolus0.5 cm bolus use in continuous days | Radiation | High Risk - Continuous bolus |
Primary outcome
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
1 secondary outcome
Interruption Time
Time frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks
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 20 Jul 2022.
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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.
Lucas G Sapienza, MD, PhD principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Bolus, Alternate Bolus and Continuous Bolus in people with Breast Cancer and Radiodermatitis, run by AC Camargo Cancer Center at 1 site in Brazil.
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 3 inclusion and 4 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 20 Jul 2022. 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 Brazil. 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.
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?
Acute radiodermatitis (time frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks). 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 20 Jul 2022.