Clinical trial NCT04257396: Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy
Official title: Multicentre Randomized Controlled Trial Of A Carbon-Fibre Adjustable Reusable Accessory (CARA) For Supine Breast Positioning To Reduce Toxicity In Whole Breast Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adjuvant Radiotherapy for Breast Cancer
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2020-02-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* 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:

* Inability to give informed consent or comply with experimental arm of trial
* 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

Primary outcomes:
measure: Rates of moist desquamation in the infra-mammary fold
timeFrame: up to two weeks post radiotherapy
Secondary outcomes:
measure: Severity of moist desquamation (MD) in the IMF
timeFrame: up to two weeks post radiotherapy
measure: NCI CTAE V 4 skin toxicity
timeFrame: up to two weeks post radiotherapy
measure: Ipsilateral Lung V20 Gy
timeFrame: prior to first treatment, 1 week
measure: Heart V25Gy
timeFrame: prior to first treatment, 1 week
measure: V50% body and V105% body
timeFrame: prior to first treatment, 1 week
measure: Dose-area predictor of moist desquamation
timeFrame: through study completion, up to 5 weeks
measure: Workflow
timeFrame: through study completion, up to 5 weeks
measure: Reproducibility of treatment setup
timeFrame: through study completion, up to 5 weeks
measure: Patient Reported Skin Toxicity
timeFrame: through study completion, up to 7 weeks
measure: User experience with the setup technique
timeFrame: through study completion, up to 5 weeks
Other outcomes:
Locations:
city: Prince George
country: Canada
facility: BC Cancer
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
References:
citation: 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.