CARA Support for Breast Cancer Radiotherapy

Recruiting at 2 trial locations

Overseen By Sara Mahdavi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must not be taking: Mepitel

Disqualifiers: Previous RT, Connective tissue disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

220 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new carbon-fiber device called CARA that supports the breast during radiation therapy. It aims to reduce skin damage and protect healthy tissues in patients receiving whole breast radiation. CARA works by positioning the breast to minimize skin folds and unnecessary radiation exposure. Earlier studies showed that CARA can reduce radiation dose to the lung and heart, and eliminate inframammary folds, which may reduce skin toxicity.

Eligibility Criteria

This trial is for adults over 18 with Stage 0-3 invasive breast cancer or DCIS, who are scheduled for adjuvant radiotherapy to the whole breast. They should have an ECOG performance status of 0-2 and some specific physical characteristics in their breast area. Excluded are those with previous chest radiation, certain medical conditions like connective tissue disease, known radiation hypersensitivity, unhealed surgical wounds or infections.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Able to provide informed consent

I have early to locally advanced breast cancer or DCIS and will get radiation therapy.

Exclusion Criteria

My surgical wound hasn't healed or got infected badly after surgery.

I am planning to undergo or have undergone breast reconstruction.

I am using Mepitel during my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive whole breast radiotherapy with or without the CARA breast support

5 weeks

Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for skin toxicity and moist desquamation up to two weeks post-radiotherapy

2 weeks

Extended Follow-up

Participants complete questionnaires and assessments on skin toxicity and user experience

up to 7 weeks

Treatment Details

Interventions

• Carbon-Fibre Adjustable Reusable Accessory (CARA)

Trial Overview The study is testing a new device called CARA (Carbon-Fibre Adjustable Reusable Accessory) designed to support the breast during radiotherapy and potentially reduce skin toxicity compared to standard supports. The goal is to see if this accessory can better protect healthy tissue from unwanted radiation doses.

Participant Groups

Group I: Arm 1 CARA Positioning Experimental Treatment 1 Intervention

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.

Group II: Arm 2 Standard of Care Active Control 1 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.

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+