Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483712
• Other study ID #: 12341234
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: November 21, 2024

Study information

• Verified date: May 2024
• Source: Nova Scotia Cancer Centre
• Contact: Hannah Dahn, MD
• Phone: 902-473-6185
• Email: Hannah.dahn[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 21, 2024
• Est. primary completion date: November 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Cancer Centre	Hannah Dahn

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year