Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
Not provided
Not provided
Not provided
Not provided
This trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (CARA) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast RT.
This study is designed to assess the effectiveness of utilizing the CARA positioning device for reducing the incidence and severity of acute skin reactions in the infra-mammary fold in patients undergoing WBRT. Secondary outcomes include patient reported outcomes and dose to normal body tissue and organs at risk. This is a randomized controlled trial. Participants will be randomly assigned to the following two arms:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 CARA Positioning | Experimental | 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 Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon-Fibre Adjustable Reuseable Accessory (CARA) | Device | Breast support device having a carbon-fibre breast cradle for supine patient positioning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of moist desquamation in the infra-mammary fold | Presence or absence of moist desquamation | up to two weeks post radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of moist desquamation (MD) in the IMF | Scoring of patch versus confluent moist desquamation | up to two weeks post radiotherapy |
| NCI CTAE V 4 skin toxicity | overall breast skin reaction scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Duzenli, PhD | Contact | 604877-6000 | 2021 | cduzenli@bccancer.bc.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer | Recruiting | Prince George | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40373801 | Derived | 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. | |
| 35725457 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Skin assessments carried out by blinded observers
| up to two weeks post radiotherapy |
| Ipsilateral Lung V20 Gy | Planned volume of ipsilateral lung receiving >=20 Gy | prior to first treatment, 1 week |
| Heart V25Gy | Planned volume of heart receiving 25Gy for left breast patients | prior to first treatment, 1 week |
| V50% body and V105% body | planned volume of body receiving >=50% and >=105% of the prescribed dose | prior to first treatment, 1 week |
| Dose-area predictor of moist desquamation | Measured dose to skin using radio-chromic film on three treatment fractions | through study completion, up to 5 weeks |
| Workflow | Measured time for treatment setup | through study completion, up to 5 weeks |
| Reproducibility of treatment setup | Shifts in patient position measured with daily and weekly imaging | through study completion, up to 5 weeks |
| Patient Reported Skin Toxicity | Questionnaire with 11 questions for patients to report pain, fatigue, skin reaction, open skin, sleep and work interruption, and comfort during treatment on 4 point scale | through study completion, up to 7 weeks |
| User experience with the setup technique | Survey with 5 questions using a 4 point scale to collect radiation therapist assessment of ease of use and overall satisfaction with the setup method | through study completion, up to 5 weeks |
| BC Cancer | Recruiting | Surrey | British Columbia | Canada |
|
| BC Cancer | Recruiting | Vancouver | British Columbia | V5Z4E6 | Canada |
|