NCT05483712

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nova Scotia Cancer Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Brass 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.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2022-08-02
• Last updated: 2024-05-22

Locations

1 site across 1 country: Canada