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Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brass Mesh Bolus
Sponsored by
Nova Scotia Cancer Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Radiation Therapy, Brass Mesh, Bolus, Skin Dose

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nova Scotia Health AuthorityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-Mastectomy Radiation Therapy Patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
July 22, 2023
Sponsor
Nova Scotia Cancer Centre
Collaborators
Hannah Dahn
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1. Study Identification

Unique Protocol Identification Number
NCT05483712
Brief Title
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
Official Title
A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
November 21, 2023 (Anticipated)
Study Completion Date
November 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Cancer Centre
Collaborators
Hannah Dahn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care). To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Radiation Therapy, Brass Mesh, Bolus, Skin Dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-Mastectomy Radiation Therapy Patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Brass Mesh Bolus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin Dose Enhancement Under Brass Mesh Bolus
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Dahn, MD
Phone
902-473-6185
Email
Hannah.dahn@nshealth.ca
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Dahn, MD
Phone
902 473-6185
Email
Hannah.dahn@nshealth.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

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