Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy

Multicentre Randomized Controlled Trial Of A Carbon-Fibre Adjustable Reusable Accessory (CARA) For Supine Breast Positioning To Reduce Toxicity In Whole Breast Adjuvant Radiotherapy

This trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (CARA) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast RT.

Study Overview

• Status: Recruiting
• Conditions: Adjuvant Radiotherapy for Breast Cancer
• Intervention / Treatment: Device: Carbon-Fibre Adjustable Reuseable Accessory (CARA)

Detailed Description

This study is designed to assess the effectiveness of utilizing the CARA positioning device for reducing the incidence and severity of acute skin reactions in the infra-mammary fold in patients undergoing WBRT. Secondary outcomes include patient reported outcomes and dose to normal body tissue and organs at risk. This is a randomized controlled trial. Participants will be randomly assigned to the following two arms:

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheryl Duzenli, PhD; Phone Number: 2021 604877-6000; Email: cduzenli@bccancer.bc.ca

Study Locations

• Canada
  • British Columbia
    • Prince George, British Columbia, Canada
      • Recruiting
      • BC Cancer
      • Contact: Robert Olson, MD
    • Surrey, British Columbia, Canada
      • Recruiting
      • BC Cancer
      • Contact: Susan Balkwill, MD
    • Vancouver, British Columbia, Canada, V5Z4E6
      • Recruiting
      • BC Cancer
      • Contact: Cheryl Duzenli, PhD; Phone Number: 2021 604877-6000; Email: cduzenli@bccancer.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 or older.
• Able to provide informed consent
• ECOG performance status 0 - 2
• Stage 0-3 invasive breast cancer or DCIS scheduled to received adjuvant radiotherapy to the whole breast
• Any infra-mammary skin fold of >= 0.5 cm in the supine treatment position and/or palpable lateral breast tissue falling posterior to the mid-axilla line while in supine or treatment position.

Exclusion Criteria:

• Inability to give informed consent or comply with experimental arm of trial
• Previous RT to either breast or to the chest
• Planned boost to infra mammary area
• Use of Mepitel while on treatment
• Failure to heal surgical wound or significant post-operative wound infection
• Presence of significant connective tissue disease (e.g. systemic sclerosis, SLE)
• Known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.)
• Breast reconstruction
• Planned partial breast irradiation, unless the treated area includes the infra-mammary fold

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 CARA Positioning; 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.	Device: Carbon-Fibre Adjustable Reuseable Accessory (CARA); Breast support device having a carbon-fibre breast cradle for supine patient positioning.
No Intervention: Arm 2 Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of moist desquamation in the infra-mammary fold	Presence or absence of moist desquamation	up to two weeks post radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of moist desquamation (MD) in the IMF	Scoring of patch versus confluent moist desquamation	up to two weeks post radiotherapy
NCI CTAE V 4 skin toxicity	overall breast skin reaction scores	up to two weeks post radiotherapy
Ipsilateral Lung V20 Gy	Planned volume of ipsilateral lung receiving >=20 Gy	prior to first treatment, 1 week
Heart V25Gy	Planned volume of heart receiving 25Gy for left breast patients	prior to first treatment, 1 week
V50% body and V105% body	planned volume of body receiving >=50% and >=105% of the prescribed dose	prior to first treatment, 1 week
Dose-area predictor of moist desquamation	Measured dose to skin using radio-chromic film on three treatment fractions	through study completion, up to 5 weeks
Workflow	Measured time for treatment setup	through study completion, up to 5 weeks
Reproducibility of treatment setup	Shifts in patient position measured with daily and weekly imaging	through study completion, up to 5 weeks
Patient Reported Skin Toxicity	Questionnaire with 11 questions for patients to report pain, fatigue, skin reaction, open skin, sleep and work interruption, and comfort during treatment on 4 point scale	through study completion, up to 7 weeks
User experience with the setup technique	Survey with 5 questions using a 4 point scale to collect radiation therapist assessment of ease of use and overall satisfaction with the setup method	through study completion, up to 5 weeks

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Collaborators: Canadian Cancer Society (CCS)

Publications and helpful links

General Publications

• Duzenli C, Chan EK, Bergman AM, Grahame S, Singer J, Burns L, Olson RA. 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. BMC Cancer. 2022 Jun 20;22(1):673. doi: 10.1186/s12885-022-09759-y.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: H19-03343

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