Clinical trial NCT04543851: CARA Treatment Pilot Study for Breast Positioning
Official title: CARA Treatment Pilot Study for Breast Positioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Side Effect
Keywords: skin dose
skin fold
organ at risk
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2020-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup
timeFrame: 12 months
measure: Number of participants having measured breast skin dose => 110% of the prescribed dose to an area of skin => 1 cm^2
timeFrame: 12 months
measure: Number of participants scoring =>6 on the CTCAE Version 4.0 skin assessment
timeFrame: 12 months
Secondary outcomes:
measure: Workflow measures
timeFrame: 12 months
measure: Setup reproducability
timeFrame: 12 months
measure: Doses to organs at risk comparison with standard of care
timeFrame: 12 months
measure: Skin assessment versus skin dose
timeFrame: 12 months
measure: Patient Reported outcome - skin reaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Cheryl R Duzenli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.