What side effects are associated with this type of intervention?

Common treatments for radiotherapy in breast cancer include whole breast radiotherapy (WBRT) and postmastectomy chest wall radiation therapy. Known side effects of these treatments often include skin toxicity, such as erythema, dry desquamation, and moist desquamation. Acute skin reactions are common, with most patients experiencing grade 1 toxicity, and a smaller percentage progressing to grade 2 or 3. Other potential side effects include fatigue, breast pain, and changes in skin texture. The CARA trial specifically aims to reduce these skin toxicities and minimize the dose to normal tissues, potentially improving patient outcomes and comfort during treatment.

What prior FDA approvals exist?

Radiotherapy is a common treatment for breast cancer, often used after surgery to eliminate remaining cancer cells. Traditional methods include external beam radiation therapy (EBRT) and brachytherapy. While specific FDA approvals for devices like the CARA carbon-fibre accessory are not detailed, advancements in radiotherapy aim to reduce skin toxicity and exposure to normal tissues. Techniques such as intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) have been developed to improve precision and outcomes in breast cancer treatment.

What other types of research exist?

Promising novel alternatives to CARA for breast support during radiotherapy for breast cancer patients include: 1) Deep Inspiration Breath Hold (DIBH) technique, which reduces radiation exposure to the heart and lungs by having patients take a deep breath and hold it during treatment. 2) Prone positioning, where patients lie on their stomachs to allow the breast to fall away from the chest wall, minimizing radiation exposure to nearby organs. 3) Advanced imaging techniques like MRI-guided radiotherapy, which provide real-time imaging to improve precision in targeting the tumor while sparing healthy tissue.

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Device

CARA Support for Breast Cancer Radiotherapy

N/A

Recruiting

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 - 2

Stage 0-3 invasive breast cancer or DCIS scheduled to received adjuvant radiotherapy to the whole breast

Must not have

Failure to heal surgical wound or significant post-operative wound infection

Use of Mepitel while on treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not directly related to CARA itself, side effects may arise from the positioning differences during radiotherapy which could include discomfort or changes in how well the treatment targets cancer versus healthy tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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My breast tissue extends beyond certain body lines when I lie down.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am using Mepitel during my treatment.

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I am scheduled for breast radiation that does not include the lower breast fold.

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I am highly sensitive to radiation due to a genetic condition.

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I have a significant connective tissue disease like lupus.

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I have had radiation therapy to my breast or chest before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two weeks post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two weeks post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two weeks post radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rates of moist desquamation in the infra-mammary fold

Secondary study objectives

Dose-area predictor of moist desquamation

Heart V25Gy

Ipsilateral Lung V20 Gy

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 CARA PositioningExperimental Treatment1 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 CareActive Control1 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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiotherapy for breast cancer primarily works by using high-energy radiation to damage the DNA of cancer cells, thereby inhibiting their ability to reproduce and causing them to die. This treatment is highly effective but requires precise targeting to minimize damage to surrounding healthy tissue. Accessories like the CARA (Carbon-fibre adjustable reusable accessory) are designed to improve breast support and positioning during radiation therapy, which enhances the accuracy of radiation delivery and reduces skin toxicity and exposure to normal tissues. This precision is crucial for maximizing the effectiveness of the treatment while minimizing side effects, ultimately improving patient outcomes.

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