To hear about similar clinical trials, please enter your email below
Trial Title:
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
NCT ID:
NCT05483712
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Radiation Therapy
Brass Mesh
Bolus
Skin Dose
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a single-site study designed to generate data quantifying the skin dose under
brass mesh bolus.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Brass Mesh Bolus
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.
Arm group label:
Post-Mastectomy Radiation Therapy Patients
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nova Scotia Health Authority
Address:
City:
Halifax
Zip:
B3H 1V7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Hannah Dahn, MD
Phone:
902 473-6185
Email:
Hannah.dahn@nshealth.ca
Start date:
January 18, 2023
Completion date:
November 21, 2024
Lead sponsor:
Agency:
Nova Scotia Cancer Centre
Agency class:
Other
Collaborator:
Agency:
Hannah Dahn
Agency class:
Other
Source:
Nova Scotia Cancer Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483712