Breast CancerNCT04543851

CARA Treatment Pilot Study for Breast Positioning

A study testing CARA - carbon fibre adjustable re-usable accessory for breast positioning in people with Breast Cancer and Side Effect, run by British Columbia Cancer Agency at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Breast Cancer, Side Effect
What is being tested?: CARA - carbon fibre adjustable re-usable accessory for breast positioning
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCanada
Study dates: 8 Oct 2018to 18 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

BC Cancer
Vancouver, British Columbia, V5T 1K9

Other trials in Canada

About this study

Read the 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.

Conditions: Breast Cancer, Side Effect
Being tested: CARA - carbon fibre adjustable re-usable accessory for breast positioning
Keywords: skin dose, skin fold, organ at risk
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CARA - carbon fibre adjustable re-usable accessory for breast positioningDevice
Breast positioning to alleviate infra-mammary fold and lateral breast sag

Study groups in NCT04543851
Study group	Role	What they receive
CARA positioning	Experimental	Planning and Treatment using the CARA Device Receives: Device: CARA - carbon fibre adjustable re-usable accessory for breast positioning

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 12 months

Secondary outcomes (5)

Workflow measures
Measured time to accomplish set up and treatment with CARA positioning
Measured: 12 months
Setup reproducability
Measure required shifts in patient position using kilo-voltage imaging
Measured: 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
Measured: 12 months
Skin assessment versus skin dose
CTCAE V4 and specific moist desquamation assessment of breast skin compared with measured skin dose-area data
Measured: 12 months
Patient Reported outcome - skin reaction
Questionnaire to assess patient reported side effects and skin reaction
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 201818 Nov 2019

First posted10 Sep 2020
Study start8 Oct 2018
Primary completion4 Nov 2019
Study completion18 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04543851
Sponsor's protocol ID: H18-02014
Status last verified: Sep 2020
First submitted: 25 Aug 2020
Last updated: 10 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40373801
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.
PubMed 34303034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CARA Treatment Pilot Study for Breast Positioning
ClinicalTrials.gov ID: NCT04543851
Acronym / sponsor ID: H18-02014
Conditions: Breast Cancer, Side Effect
Keywords: skin dose, skin fold, organ at risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: British Columbia Cancer AgencyUniversity, hospital or other
Collaborators: Canadian Cancer Society (CCS)
Study start: 8 Oct 2018 (actual)
Primary completion: 4 Nov 2019 (actual)
Study completion: 18 Nov 2019 (actual)
First posted: 10 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CARA positioning	Experimental	Device: CARA - carbon fibre adjustable re-usable accessory for breast positioningPlanning and Treatment using the CARA Device

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CARA - carbon fibre adjustable re-usable accessory for breast positioningBreast positioning to alleviate infra-mammary fold and lateral breast sag	Device	CARA positioning

Primary outcome

Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup
Time frame: 12 months
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
Number of participants having measured breast skin dose => 110% of the prescribed dose to an area of skin => 1 cm^2
Time frame: 12 months
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.
Number of participants scoring =>6 on the CTCAE Version 4.0 skin assessment
Time frame: 12 months
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.

5 secondary outcomes

Workflow measures
Time frame: 12 months
Setup reproducability
Time frame: 12 months
Doses to organs at risk comparison with standard of care
Time frame: 12 months
Skin assessment versus skin dose
Time frame: 12 months
Patient Reported outcome - skin reaction
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Derived from this study: PubMed 40373801Malhotra 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.
Derived from this study: PubMed 34303034Duzenli 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.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

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Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
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RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cheryl R Duzenli, PhD principal investigator

BC Cancer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CARA - carbon fibre adjustable re-usable accessory for breast positioning in people with Breast Cancer and Side Effect, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04543851, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.