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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

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