Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

July 22, 2023 updated by: Thalat Monajemi, Nova Scotia Cancer Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • Nova Scotia Health Authority
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-Mastectomy Radiation Therapy Patients
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Dose Enhancement Under Brass Mesh Bolus
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Cancer Centre

Collaborators

Hannah Dahn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

November 21, 2023

Study Completion (Estimated)

November 21, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12341234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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