An interventional study of Brass Mesh Bolus in Breast Cancer, sponsored by Nova Scotia Cancer Centre. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Nova Scotia Cancer Centre · Not applicable, Interventional, and Treatment
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.
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Nova Scotia Cancer Centre is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Time frame: through study completion, an average of 1 year
Plan to share: Yes
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nova Scotia Cancer Centre