Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy
NCT ID: NCT04257396
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2020-06-11
2024-12-31
Brief Summary
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Detailed Description
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Arm 1 patients will receive CARA breast support. The known benefits to using CARA for breast positioning are reduction in IMF skin folds during treatment, reduction in breast separation, and reduction in V50% body, V105% body and lung V20 Gy in treatment planning. No known risks to using CARA have been identified.
Arm 2 patients will not receive CARA breast support. Patients in arm 2 may be treated with no breast support, a small foam wedge, a thermoplastic shell or alternate supine breast support method according to the current standard of care at the treating centre. These methods have entered RT clinical practice over decades of practice without published evidence of impact on rates of MD. Published rates of MD for the control arm thus pertain to a cross section of these methods. The control arm of this study will look at all of these methods combined. There may be centre specific preference for the control method and stratification by centre will be done.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Arm 1 CARA Positioning
Arm 1 patients will receive CARA breast support. The known benefits to using CARA for breast positioning are reduction in IMF skin folds during treatment, reduction in breast separation, and reduction in V50% body, V105% body and lung V20 Gy in treatment planning. No known risks to using CARA have been identified.
Carbon-Fibre Adjustable Reuseable Accessory (CARA)
Breast support device having a carbon-fibre breast cradle for supine patient positioning.
Arm 2 Standard of Care
Arm 2 patients will not receive CARA breast support. Patients in arm 2 may be treated with no breast support, a small foam wedge, a thermoplastic shell or alternate supine breast support method according to the current standard of care at the treating centre. These methods have entered RT clinical practice over decades of practice without published evidence of impact on rates of MD. Published rates of MD for the control arm thus pertain to a cross section of these methods. The control arm of this study will look at all of these methods combined. There may be centre specific preference for the control method and stratification by centre will be done.
No interventions assigned to this group
Interventions
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Carbon-Fibre Adjustable Reuseable Accessory (CARA)
Breast support device having a carbon-fibre breast cradle for supine patient positioning.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* ECOG performance status 0 - 2
* Stage 0-3 invasive breast cancer or DCIS scheduled to received adjuvant radiotherapy to the whole breast
* Any infra-mammary skin fold of \>= 0.5 cm in the supine treatment position and/or palpable lateral breast tissue falling posterior to the mid-axilla line while in supine or treatment position.
Exclusion Criteria
* Previous RT to either breast or to the chest
* Planned boost to infra mammary area
* Use of Mepitel while on treatment
* Failure to heal surgical wound or significant post-operative wound infection
* Presence of significant connective tissue disease (e.g. systemic sclerosis, SLE)
* Known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.)
* Breast reconstruction
* Planned partial breast irradiation, unless the treated area includes the infra-mammary fold
18 Years
ALL
No
Sponsors
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Canadian Cancer Society (CCS)
OTHER
British Columbia Cancer Agency
OTHER
Responsible Party
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Cheryl Duzenli
Medical Physicist
Locations
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BC Cancer
Prince George, British Columbia, Canada
BC Cancer
Surrey, British Columbia, Canada
BC Cancer
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Robert Olson, MD
Role: primary
Susan Balkwill, MD
Role: primary
References
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Malhotra A, Chan EK, Nichol A, Duzenli C. Spatial dose-distribution-based risk mapping to predict moist desquamation in breast radiotherapy. Phys Med Biol. 2025 May 27;70(11). doi: 10.1088/1361-6560/add985.
Duzenli C, Chan EK, Bergman AM, Grahame S, Singer J, Burns L, Olson RA. A novel carbon-fibre adjustable reusable accessory (CARA) for supine breast positioning to reduce toxicity in breast adjuvant radiotherapy: a study protocol for a multicentre phase III randomized controlled trial. BMC Cancer. 2022 Jun 20;22(1):673. doi: 10.1186/s12885-022-09759-y.
Other Identifiers
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H19-03343
Identifier Type: -
Identifier Source: org_study_id
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