CARA Treatment Pilot Study for Breast Positioning

NCT04543851 | Completed

• 1 other identifier: H18-02014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Side Effect

Keywords

skin dose; skin fold; organ at risk

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Workflow measures

  12 months

• Setup reproducability

  12 months

• Doses to organs at risk comparison with standard of care

  12 months

• Skin assessment versus skin dose

  12 months

• Patient Reported outcome - skin reaction

  12 months

Study Arms (1)

CARA positioning

EXPERIMENTAL

Planning and Treatment using the CARA Device

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

Interventions

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

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

CARA positioning

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5T 1K9, Canada

Location

Related Publications (2)

• Malhotra A, Chan EK, Nichol A, Duzenli C. Spatial dose-distribution-based risk mapping to predict moist desquamation in breast radiotherapy. Phys Med Biol. 2025 May 27;70(11). doi: 10.1088/1361-6560/add985.

  PMID: 40373801 DERIVED

• 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.

  PMID: 34303034 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cheryl R Duzenli, PhD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physicist

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 10, 2020
• Study Start: October 8, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 18, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)