Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

NCT05483712 | Recruiting DMC

• 1 other identifier: 12341234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: Brass Mesh Bolus

Interventions

Brass Mesh Bolus DEVICE

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.

Post-Mastectomy Radiation Therapy Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Cancer Centre: lead
• Hannah Dahn: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hannah Dahn, MD

CONTACT

902-473-6185; Hannah.dahn@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physicist

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

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: January 18, 2023
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)