CARA Treatment Pilot Study for Breast Positioning

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Side Effect
• Intervention / Treatment: Device: CARA - carbon fibre adjustable re-usable accessory for breast positioning

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5T 1K9
      • BC Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARA positioning; Planning and Treatment using the CARA Device	Device: CARA - carbon fibre adjustable re-usable accessory for breast positioning; Breast positioning to alleviate infra-mammary fold and lateral breast sag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup	Treatment planning dose constraints are: >=95% of the prescribed dose covering >=98% of the breast target tissue, including internal mammary chain when requested by the treating oncologist volume of ipsi-lateral lung receiving >= 20Gy should be <=35% volume of heart receiving >=25Gy should be <=5% maximum dose to any point in the body <=110% of the prescribed dose volume of breast receiving >=107% of prescribed dose should be <=22 cm^3	12 months
Number of participants having measured breast skin dose => 110% of the prescribed dose to an area of skin => 1 cm^2	Skin dose is measured on the breast surface under the carbon fibre device using radio-chromic film. The area of skin receiving 70% of the prescribed dose up to the maximum absorbed dose is measured in 5% dose increments to an accuracy of 0.5 cm^2. If any participant receives => 110% of the prescribed dose to >=1 cm^2 area of skin, the study will be stopped.	12 months
Number of participants scoring =>6 on the CTCAE Version 4.0 skin assessment	Participants will undergo a detailed breast skin assessment at baseline, one week prior to RT completion, last week of RT, and one and two weeks post RT using the CTCAE Version 4 skin assessment scoring system as well as examination of the infra-mammary fold for any moist desquamation. The dimensions and location of moist desquamation will be recorded. In the event that a skin reaction of ≥ 6 (indicating ulceration, hemorrhage or necrosis) on the CTCAE V 4.0 scale is reported, the trial will be stopped.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workflow measures	Measured time to accomplish set up and treatment with CARA positioning	12 months
Setup reproducability	Measure required shifts in patient position using kilo-voltage imaging	12 months
Doses to organs at risk comparison with standard of care	Comparison of lung, heart, breast and normal tissue dose versus standard of care	12 months
Skin assessment versus skin dose	CTCAE V4 and specific moist desquamation assessment of breast skin compared with measured skin dose-area data	12 months
Patient Reported outcome - skin reaction	Questionnaire to assess patient reported side effects and skin reaction	12 months

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Collaborators: Canadian Cancer Society (CCS)
• Investigators: Principal Investigator: Cheryl R Duzenli, PhD, BC Cancer

Publications and helpful links

General Publications

• Duzenli C, Koulis T, Menna T, Carpentier E, Arora T, Coope R, Gill B, Lim P, Aquino-Parsons C, Nichol A, Singer J, Ingledew PA, Grahame S, Chan EK. Reduction in Doses to Organs at Risk and Normal Tissue During Breast Radiation Therapy With a Carbon-Fiber Adjustable Reusable Accessory. Pract Radiat Oncol. 2021 Nov-Dec;11(6):470-479. doi: 10.1016/j.prro.2021.06.012. Epub 2021 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: skin dose; skin fold; organ at risk
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: H18-02014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No