Breast CancerNCT05483712
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
A study testing Brass Mesh Bolus in people with Breast Cancer, run by Nova Scotia Cancer Centre at 1 site in Canada.
Trial summary
The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Brass Mesh Bolus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2023to 21 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women undergoing rotational chest wall radiotherapy following mastectomy for breast cancer treatment who would utilize Superflab bolus on some, but not all, days of radiotherapy treatment.
Who cannot join
- Patients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7
Hannah Dahn, MD, 902 473-6185, Hannah.dahn@nshealth.ca
About this study
Official title: A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus
The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.
Read the detailed description
Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.
Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.
Primary outcome
- To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
- To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.
- Conditions
- Breast Cancer
- Being tested
- Brass Mesh Bolus
- Keywords
- Breast Cancer, Radiation Therapy, Brass Mesh, Bolus, Skin Dose
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brass Mesh BolusDevice
During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.
| Study group | Role | What they receive |
|---|---|---|
| Post-Mastectomy Radiation Therapy Patients | Experimental | Any patient who is going through radiation to their chest wall following mastectomy using a rotational delivery technique and 6 MV, and uses Superflab bolus for some but not all fractions of radiotherapy Receives: Device: Brass Mesh Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Dose Enhancement Under Brass Mesh Bolus
During days one, two, and three of radiation therapy, patients on this study utilize no-bolus, 5-mm thick Superflab bolus, and brass mesh bolus, respectively. Each day, nine in-vivo dosimeters (OSLDs) will be placed on patient skin to sample the skin dose in cGy. As a result, for each patient on this study, skin dose enhancement of brass mesh compared with no-bolus can be related to that of Superflab bolus. At the end of the study, the average and range of skin dose enhancement under brass mesh bolus for a sample size of twenty patients will be reported.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start18 Jan 2023
- Primary completion21 Nov 2024 (estimated)
- Study completion21 Nov 2024 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Hannah Dahn
- Responsible party
- Principal investigator, Thalat Monajemi, Nova Scotia Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483712
- Sponsor's protocol ID
- 12341234
- Status last verified
- May 2024
- First submitted
- 25 Jul 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus
- ClinicalTrials.gov ID
- NCT05483712
- Acronym / sponsor ID
- 12341234
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Radiation Therapy, Brass Mesh, Bolus, Skin Dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Scotia Cancer CentreUniversity, hospital or other
- Collaborators
- Hannah Dahn
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 21 Nov 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 2 Aug 2022 (actual)
- 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 hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.
Detailed description
Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.
Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.
Primary outcome
- To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
- To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.
| Arm | Type | Receives |
|---|---|---|
| Post-Mastectomy Radiation Therapy Patients | Experimental | Device: Brass Mesh BolusAny patient who is going through radiation to their chest wall following mastectomy using a rotational delivery technique and 6 MV, and uses Superflab bolus for some but not all fractions of radiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing rotational chest wall radiotherapy following mastectomy for breast cancer treatment who would utilize Superflab bolus on some, but not all, days of radiotherapy treatment.
Key exclusion criteria (1 listed)
- Patients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.
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 |
|---|---|---|
| Brass Mesh BolusDuring a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes. | Device | Post-Mastectomy Radiation Therapy Patients |
Primary outcome
Skin Dose Enhancement Under Brass Mesh Bolus
Time frame: through study completion, an average of 1 year
During days one, two, and three of radiation therapy, patients on this study utilize no-bolus, 5-mm thick Superflab bolus, and brass mesh bolus, respectively. Each day, nine in-vivo dosimeters (OSLDs) will be placed on patient skin to sample the skin dose in cGy. As a result, for each patient on this study, skin dose enhancement of brass mesh compared with no-bolus can be related to that of Superflab bolus. At the end of the study, the average and range of skin dose enhancement under brass mesh bolus for a sample size of twenty patients will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brass Mesh Bolus in people with Breast Cancer, run by Nova Scotia Cancer Centre at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 May 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Dahn, MD (902-473-6185, Hannah.dahn@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Dose Enhancement Under Brass Mesh Bolus (time frame: through study completion, an average of 1 year). 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 22 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.