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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 7 weeks
Awards & highlights
Study Summary
This trial is comparing a new type of breast support to the current standard to see if it reduces skin toxicity and unwanted normal tissue dose during whole breast radiation therapy.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rates of moist desquamation in the infra-mammary fold
Secondary outcome measures
Dose-area predictor of moist desquamation
Heart V25Gy
Ipsilateral Lung V20 Gy
+7 moreTrial 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.
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,291 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,525 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I can take care of myself and am up and about more than half of my waking hours.I have early to locally advanced breast cancer or DCIS and will get radiation therapy.I am scheduled for breast radiation that does not include the lower breast fold.I am scheduled for additional radiation treatment to the lower breast area.I am highly sensitive to radiation due to a genetic condition.I have a significant connective tissue disease like lupus.I am 18 years old or older.My breast tissue extends beyond certain body lines when I lie down.I have had radiation therapy to my breast or chest before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 CARA Positioning
- Group 2: Arm 2 Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are the most allowed in this clinical experiment?
"Correct. Clinicaltrials.gov disclosures that this clinical trial, originally posted on June 11th 2020, is still recruiting participants. The study requires 220 patients from 1 site to complete it."
Answered by AI
Are any additional participants sought for this trial?
"Affirmative, according to clinicaltrials.gov this research is still open for participants as of today. It was initially posted on June 11th 2020 and has been revised most recently on July 19th 2021. A total of 220 test subjects are needed at one location."
Answered by AI
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