CARA Treatment Pilot Study for Breast Positioning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2019-11-18

Brief Summary

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CARA is a novel Carbon-fibre Adjustable and Re-usable Accessory for supine breast positioning during radiation therapy. CARA was developed at BC Cancer. 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 designed to remove the infra-mammary skin fold and lateral breast droop which can lead to unwanted dose to normal tissue.

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Detailed Description

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This pilot study will investigate the safety and potential benefits of CARA breast positioning by treating 20 patients using the device. Patients will be planned with CARA positioning and standard of care positioning. CARA plans will be evaluated to ensure all treatment planning goals are met and patients will proceed to treatment with CARA positioning. This pilot study will ensure that patients can be safely treated with the CARA and provide us with valuable information from therapists, oncologists and patients about the performance of the current design. This will also inform the direction of design improvements and the production of educational materials for training practitioners in the use of the device. Overall, this will prepare us for a randomized clinical trial of the CARA positioning technique versus current standard of practice to assess whether reduced toxicity can be achieved using the CARA technique.

Conditions

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Breast Cancer Side Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CARA positioning

Planning and Treatment using the CARA Device

Group Type EXPERIMENTAL

CARA - carbon fibre adjustable re-usable accessory for breast positioning

Intervention Type DEVICE

Breast positioning to alleviate infra-mammary fold and lateral breast sag

Interventions

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CARA - carbon fibre adjustable re-usable accessory for breast positioning

Breast positioning to alleviate infra-mammary fold and lateral breast sag

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients diagnosed with completely excised stage I or II invasive breast cancer, or ductal carcinoma in situ (DCIS), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy;

Any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than D;

Patients undergoing nodal radiotherapy are eligible if the above criteria are met;

Patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast;

Language is not a barrier if there are interpreters/family members to translate;

Patients having had chemotherapy are eligible for this study;

Exclusion Criteria

Inability to give informed consent or comply with requirements of the trial;

Failure of healing of the surgical scar or significant post-operative wound infection;

Prior radiotherapy to either breast or to the chest;

Presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia);

Inability to return for assessment at both one week and two weeks following completion of radiotherapy;

Breast reconstruction;

Use of Mepitel® wound dressing product.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No