Adjuvant Radiotherapy for Breast CancerNCT04257396
Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy
A study testing Carbon-Fibre Adjustable Reuseable Accessory (CARA) in people with Adjuvant Radiotherapy for Breast Cancer, run by British Columbia Cancer Agency at 3 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjuvant Radiotherapy for Breast Cancer
- What is being tested?
- Carbon-Fibre Adjustable Reuseable Accessory (CARA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Jun 2020to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.)
- Breast reconstruction
- Planned partial breast irradiation, unless the treated area includes the infra-mammary fold
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
BC Cancer
Prince George, British Columbia
Robert Olson, MD
- Recruiting
BC Cancer
Surrey, British Columbia
Susan Balkwill, MD
- Recruiting
BC Cancer
Vancouver, British Columbia, V5Z4E6
Cheryl Duzenli, PhD, 604877-6000 ext. 2021, cduzenli@bccancer.bc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Adjuvant Radiotherapy for Breast Cancer
- Being tested
- Carbon-Fibre Adjustable Reuseable Accessory (CARA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon-Fibre Adjustable Reuseable Accessory (CARA)Device
Breast support device having a carbon-fibre breast cradle for supine patient positioning.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 CARA Positioning | Experimental | 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. Receives: Device: Carbon-Fibre Adjustable Reuseable Accessory (CARA) |
| Arm 2 Standard of Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Rates of moist desquamation in the infra-mammary fold
Presence or absence of moist desquamation
Measured: up to two weeks post radiotherapy
Secondary outcomes (10)
Severity of moist desquamation (MD) in the IMF
Scoring of patch versus confluent moist desquamation
Measured: up to two weeks post radiotherapy
NCI CTAE V 4 skin toxicity
overall breast skin reaction scores
Measured: up to two weeks post radiotherapy
Ipsilateral Lung V20 Gy
Planned volume of ipsilateral lung receiving >=20 Gy
Measured: prior to first treatment, 1 week
Heart V25Gy
Planned volume of heart receiving 25Gy for left breast patients
Measured: prior to first treatment, 1 week
V50% body and V105% body
planned volume of body receiving >=50% and >=105% of the prescribed dose
Measured: prior to first treatment, 1 week
Dose-area predictor of moist desquamation
Measured dose to skin using radio-chromic film on three treatment fractions
Measured: through study completion, up to 5 weeks
Workflow
Measured time for treatment setup
Measured: through study completion, up to 5 weeks
Reproducibility of treatment setup
Shifts in patient position measured with daily and weekly imaging
Measured: 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
Measured: 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
Measured: through study completion, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Jun 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Adjuvant Radiotherapy for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Cheryl Duzenli, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257396
- Sponsor's protocol ID
- H19-03343
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 40373801Duzenli 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.
PubMed 35725457
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Controlled Trial Of A Carbon-Fibre Adjustable Reusable Accessory (CARA) For Supine Breast Positioning To Reduce Toxicity In Whole Breast Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT04257396
- Acronym / sponsor ID
- H19-03343
- Conditions
- Adjuvant Radiotherapy for Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 CARA Positioning | Experimental | Device: Carbon-Fibre Adjustable Reuseable Accessory (CARA)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 Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Carbon-Fibre Adjustable Reuseable Accessory (CARA)Breast support device having a carbon-fibre breast cradle for supine patient positioning. | Device | Arm 1 CARA Positioning |
Primary outcome
Rates of moist desquamation in the infra-mammary fold
Time frame: up to two weeks post radiotherapy
Presence or absence of moist desquamation
10 secondary outcomes
Severity of moist desquamation (MD) in the IMF
Time frame: up to two weeks post radiotherapy
NCI CTAE V 4 skin toxicity
Time frame: up to two weeks post radiotherapy
Ipsilateral Lung V20 Gy
Time frame: prior to first treatment, 1 week
Heart V25Gy
Time frame: prior to first treatment, 1 week
V50% body and V105% body
Time frame: prior to first treatment, 1 week
Dose-area predictor of moist desquamation
Time frame: through study completion, up to 5 weeks
Workflow
Time frame: through study completion, up to 5 weeks
Reproducibility of treatment setup
Time frame: through study completion, up to 5 weeks
Patient Reported Skin Toxicity
Time frame: through study completion, up to 7 weeks
User experience with the setup technique
Time frame: through study completion, up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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 35725457Duzenli 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.
- Individual participant dataSharing planned: No
Related trials for Adjuvant Radiotherapy for Breast Cancer
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
Recruiting
Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)
Breast Cancer
Recruiting
5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Breast Cancer
Active, not recruitingObservational study
Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible
Breast Cancer
Recruiting
Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions
Ductal Carcinoma in Situ, Breast Cancer
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon-Fibre Adjustable Reuseable Accessory (CARA) in people with Adjuvant Radiotherapy for Breast Cancer, run by British Columbia Cancer Agency at 3 sites 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Duzenli, PhD (604877-6000 ext. 2021, cduzenli@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of moist desquamation in the infra-mammary fold (time frame: up to two weeks post radiotherapy). 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 NCT04257396, 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 25 Jan 2023.