HYPO-BL: Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial –Ultra versus Moderate Breast Hypofractionation Radiation Treatment

Not Applicable

• Conditions: Breast Lymphoedema in Breast cancer patients receiving radiotherapy; Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12623001172695
• Lead Sponsor: Gosford Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-14
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.Women aged 50 years or older
2. Unilateral DCIS or early-stage invasive breast cancer (Stage Tis-T3, N0, M0)
3. Breast conservation surgery
4. Complete microscopic resection i.e. negative margins
5. Neoadjuvant systemic therapy to downstage cT3-T4 breast cancer is accepted if there is not an indication to irradiate the lymph nodes or treat with bolus
6. Ability to understand and willingness to sign written informed consent
7. Available for 2 years of face-to face follow-up

Exclusion Criteria

1. Prior history of breast cancer or DCIS
2. Bilateral breast cancer or bilateral breast surgery (e.g. symmetrising surgery)
3. History of breast implants or breast reconstructive surgery in either breast
4. Use of bolus during radiotherapy
5. Prone breast radiation treatment
6. Conditions where the patient cannot complete radiation treatment or attend follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial e.g. language problems.
7. Unwilling or unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the incidence of breast oedema when treating with a moderately hypofractionated radiation schedule compared to an accelerated ultra-hypofractionated schedule. Breast oedema defined as Tissue dielectric constant (TDC) ratio greater than or equal to 1..40.[ Whole breast TDC ratio based on measurements prior to commencing radiotherapy, then at 3, 6, 12 and 24 months after breast radiotherapy]