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Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05483712
Enrollment
20
Registered
2022-08-02
Start date
2023-01-18
Completion date
2024-11-21
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Radiation Therapy, Brass Mesh, Bolus, Skin Dose

Brief 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.

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 1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care). 2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.

Interventions

DEVICEBrass Mesh Bolus

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.

Sponsors

Hannah Dahn
CollaboratorUNKNOWN
Nova Scotia Cancer Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Patients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.

Design outcomes

Primary

MeasureTime frameDescription
Skin Dose Enhancement Under Brass Mesh Bolusthrough study completion, an average of 1 yearDuring 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.

Countries

Canada

Contacts

Primary ContactHannah Dahn, MD
Hannah.dahn@nshealth.ca902-473-6185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026