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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    220
  • sponsor
    British Columbia Cancer Agency
Updated on 25 January 2021

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.

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.

Details
Condition Adjuvant Radiotherapy for Breast Cancer
Treatment Carbon-Fibre Adjustable Reuseable Accessory (CARA)
Clinical Study IdentifierNCT04257396
SponsorBritish Columbia Cancer Agency
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Adjuvant Radiotherapy for Breast Cancer?
Do you have any of these conditions: Do you have Adjuvant Radiotherapy for Breast Cancer??
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 or 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.)
Inability to either return for skin assessments or to be assessed by Telehealth one and two weeks post WBRT
Breast reconstruction
Planned partial breast irradiation
Clear my responses

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