Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: Brass Mesh Bolus

• Registration Number: NCT05483712
• Lead Sponsor: Nova Scotia Cancer Centre

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.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-02
• Study Start: 2023-01-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-11-21
• Study Completion: 2024-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-Mastectomy Radiation Therapy Patients	Brass Mesh Bolus	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

Primary Outcome Measures

Name	Time	Method
Skin Dose Enhancement Under Brass Mesh Bolus	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.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada