A novel carbon-fibre adjustable reusable accessory (CARA) for supine breast positioning to reduce toxicity in breast adjuvant radiotherapy: a study protocol for a multicentre phase III randomized controlled trial

Cheryl Duzenli, Elisa K Chan, Alanah M Bergman, Sheri Grahame, Joel Singer, Levi Burns, Robert A Olson, Cheryl Duzenli, Elisa K Chan, Alanah M Bergman, Sheri Grahame, Joel Singer, Levi Burns, Robert A Olson

Abstract

Background: A novel device for supine positioning in breast radiotherapy for patients with large or pendulous breasts has been developed and tested in phase II studies. This trial is designed to assess the efficacy of the device to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during breast radiotherapy.

Methods: Patients at high risk for moist desquamation, having infra-mammary fold or lateral ptosis, will be randomized into two arms. Patients in the control arm will receive breast radiotherapy with supine positioning using current standard of care. Patients in the experimental arm will be positioned supine with the novel device. The primary endpoint is the incidence of moist desquamation in the infra-mammary fold. We hypothesize a 20% reduction (from 50 to 30%) in the rate of moist desquamation in the study arm versus the control arm. For 80% power, two-tailed α = 0.05 and 10% loss to follow up, 110 patients will be assigned to each arm. The proportion of patients experiencing moist desquamation in the two arms will be compared using logistic regression adjusting for brassiere cup size, skin fold size, body mass index, smoking status, and dose fractionation schedule. An unadjusted comparison will also be made using the chi-square test, or Fisher's exact test, if appropriate. Secondary endpoints include dose-volume statistics for the lung and heart, skin dose and clinical parameters including setup time, reproducibility, and staff experience with setup procedures. Patient-reported pain, skin condition interference with sleep and daily activities, and comfort during treatment are also secondary endpoints.

Discussion: Based on results from earlier phase II studies, it is expected that the device-enabled elimination of infra-mammary fold should reduce toxicity and improve quality of life for this patient population. Earlier studies showed reduction in dose to organs at risk including lung and heart, indicating potential for other long-term benefits for patients using the device. This study is limited to acute skin toxicity, patient-reported outcomes, and clinical factors to inform integration of the device into standard breast radiotherapy procedures.

Trial registration: Clinicaltrials.gov identifier: NCT04257396 . Registered February 6 2020.

Keywords: Adjuvant radiotherapy; Breast cancer; Breast support; Infra-mammary fold; Moist desquamation; Patient-reported outcomes; Quality of life; Skin toxicity; Supine positioning.

Conflict of interest statement

CD has a patent pending (PCT/CA2018/050233 Apparatus for Positioning a Breast for Radiation Treatment). There are no other competing interests for any of the authors.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient without CARA support (a) and with CARA support (b). The CARA carbon fibre cradle supporting the breast is visible
Fig. 2
Fig. 2
Axial CT images of the patient shown in Fig. 1 without CARA (a) and with CARA (b). The tangential beams and target volume are shown
Fig. 3
Fig. 3
Study schema for each participant from identification and eligibility screening to study completion

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