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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breast support device called CARA (Carbon-Fibre Adjustable Reusable Accessory) during radiotherapy for breast cancer. The researchers aim to determine if CARA can reduce skin irritation and unwanted radiation exposure to normal tissues compared to standard methods. Participants will either use CARA or receive standard breast support, such as foam wedges or other devices. Individuals with stage 0-3 invasive breast cancer or DCIS (a type of early breast cancer) scheduled for whole breast radiotherapy, who experience skin folds or have certain breast tissue positions when lying down, may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance comfort and outcomes during radiotherapy.

What prior data suggests that the CARA device is safe for breast cancer radiotherapy?

Research shows that the Carbon-Fibre Adjustable Reusable Accessory (CARA) is being tested for safety and effectiveness in breast cancer radiation treatment. Earlier studies with CARA have shown good results. These studies found that CARA reduces skin folds under the breast during treatment and lowers radiation exposure to healthy tissues like the lungs. This reduction is important because it can help minimize side effects.

Regarding safety, no known risks are associated with using CARA. Previous patient studies evaluated its safety and integration into treatment routines, reporting no negative effects linked to the device. This suggests that CARA is well-tolerated by patients. Overall, existing evidence supports the safety of CARA for patients receiving breast cancer radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARA Support for Breast Cancer Radiotherapy because it offers a new way to position the breast during treatment, which could significantly improve patient outcomes. Unlike standard methods like foam wedges or thermoplastic shells, CARA uses a carbon-fiber adjustable reusable accessory to minimize skin folds and reduce breast separation. This innovative approach is designed to decrease radiation exposure to healthy tissues, such as the lungs, potentially lowering side effects and enhancing the precision of radiotherapy. By improving treatment accuracy, CARA has the potential to make radiation therapy safer and more effective for breast cancer patients.

What evidence suggests that the CARA device is effective for reducing skin toxicity in breast cancer radiotherapy?

Research has shown that the Carbon-Fibre Adjustable Reusable Accessory (CARA), which participants in this trial may receive, aids in breast cancer radiation treatment for patients with larger or sagging breasts. The CARA device reduces skin folds during treatment, lowering skin damage and preventing unnecessary radiation to healthy areas. Studies have found that CARA reduces the amount of tissue exposed to high radiation doses, benefiting the patient's health. Made from carbon fiber, a strong yet lightweight material, the device offers better support and positioning during treatment. Overall, these early findings suggest that CARA could make breast cancer radiation treatment safer and more effective. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09759-y

A novel carbon-fibre adjustable reusable accessory (CARA ... A novel device for supine positioning in breast radiotherapy for patients with large or pendulous breasts has been developed and tested in phase II studies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04257396

Carbon-Fibre Accessory (CARA) for Supine Breast ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35725457/

A novel carbon-fibre adjustable reusable accessory (CARA ... This trial is designed to assess the efficacy of the device to reduce skin toxicity and unwanted normal tissue dose in comparison to the current ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1879850021002010

Reduction in Doses to Organs at Risk and Normal Tissue ... Carbon fiber composites are low-density materials with high tensile strength that can provide the needed support for large and pendulous breasts while ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04257396/carbon-fibre-accessory-cara-for-supine-breast-positioning-to-reduce-toxicity-in-whole-breast-radiotherapy

Carbon-Fibre Accessory (CARA) for Supine Breast ... This study is designed to assess the effectiveness of utilizing the CARA positioning device for reducing the incidence and severity of acute ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34303034/

Reduction in Doses to Organs at Risk and Normal Tissue ... CARA can reduce V105% breast, lung and normal tissue dose, and remove the inframammary fold for breast patients with large or pendulous breasts and high body ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04543851?cond=Position%20effect&viewType=Table&rank=9

CARA Treatment Pilot Study for Breast Positioning In this study, twenty patients will be planned and treated with CARA positioning to establish safety and workflow measures of this novel device. The device is ...