Recruiting

CARA

Sponsor:

British Columbia Cancer Agency

Code:

NCT04257396

Conditions

Adjuvant Radiotherapy for Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carbon-Fibre Adjustable Reuseable Accessory (CARA)

Study Details

Brief 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.

Conditions

Adjuvant Radiotherapy for Breast Cancer

Study ID

NCT04257396

Start date

Jun 11, 2020

Status verified date

Jan, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Carbon-Fibre Adjustable Reuseable Accessory (CARA)

Breast support device having a carbon-fibre breast cradle for supine patient positioning.

Primary outcome measure

  • Rates of moist desquamation in the infra-mammary fold [ Time Frame: up to two weeks post radiotherapy ]

Central Contacts and Locations

Central contacts

Cheryl Duzenli, PhD

604877-6000cduzenli@bccancer.bc.ca

Locations

BC Cancer

Recruiting

Prince George, British Columbia, Canada

BC Cancer

Recruiting

Surrey, British Columbia, Canada

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Cheryl Duzenli, PhD

604877-6000cduzenli@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jan 25, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2023-01-25.