ymph node grafting for breast cancer related lymphoedema

Phase 2

Active, not recruiting

• Conditions: ymphoedema; Lymphoedema; Surgery - Surgical techniques; Cancer - Breast

• Registration Number: ACTRN12617000951358
• Lead Sponsor: Mr Winston McEwan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-04
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

1) Ipsilateral upper limb lymphoedema of severity stage one (but requiring the regular use of a compression garment) or stage two (ISL staging system).
2) Meets definition of lymphoedema: has either a 200 ml inter-limb volume difference, or a 10% difference in limb volume.
3) Previously treated stage 1-3 breast cancer.
4) Undergone local standard lymphoedema therapy for at least three months prior to enrolment and continued participation with techniques.
5) Fit for operative procedure.

Exclusion Criteria

1) Metastatic breast cancer;
2) Past history of other malignancy with potential lymphatic drainage to either axillae;
3) BMI >40;
4) Current smoker;
5) Congestive heart failure;
6) low serum albumin (<32g/L);
7) Poorly controlled diabetes (bA1c > 70mm/L);
8) Steroid medication;
9) Previous lymph node grafting.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ymphoedema Volume (LV): Expressed as the inter-limb Truncal Cone Volume (TCV) difference and change (including percentage) from baseline. A clinically significant change will be taken as >10% or 80 ml reduction from baseline.[ 60 months. ]