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The Lymph Node Grafting clinical trial

Purpose

This trial will compare the novel surgical technique of lymph node grafting in addition to standard lymphoedema therapy against standard lymphoedema therapy alone. Clinical trial participants will be those with residual stage one to two breast-cancer related lymphoedema despite initial treatment with standard lymphoedema therapy. Participants are randomised to either surgery plus standard therapy or standard therapy alone.
 
The surgical procedure involves lymph node grafting from groin to upper limb. This technique is carried out by trained Plastic and Breast Surgeons and involves an incision in the groin with removal of two lymph nodes under general anaesthetic. Lymph nodes are then grafted into the subcutaneous tissue of the elbow and wrist of the affected limb. Surgeons have a minimum of five years experience and the surgery is carried out in one surgical procedure and takes approximately 60 minutes.

Scientific Title

Lymph node grafting for upper limb lymphoedema following breast cancer treatment

Background

Upper limb lymphoedema is a common and often distressing side effect of breast cancer treatment. Reconstructive lymphatic microsurgery may be considered if conservative treatment fails but is highly specialized and expensive.

Enrolment

The trial is open to women in New Zealand that meet the following criteria:

  • upper limb lymphoedema* of severity stage one (but requiring the regular use of a compression garment) or stage two (ISL staging system)
  • previously treated stage 1-3 breast cancer
  • undergone local standard lymphoedema therapy for at least three months prior to enrolment and continues participation with techniques
  • fit for operative procedure

*definition of lymphoedema being: has either a 200ml inter-limb difference or a 10% difference in limb volume.

Note key exclusion criteria are:
  • advanced breast cancer
  • past history of other malignancy with potential lymphatic drainage to either axillae
  • BMI >40
  • current smoker
  • congestive heart failure
  • low serum albumin (<32g/L)
  • poorly controlled diabetes (HbA1c > 70mm/L)
  • taking steroid medication

This clinical trial has been made possible by a grant from the Cancer Society of New Zealand, support for surgery from Alison Surgical Centre and Braemar Hospital. Funds raised from the Fine Homes Tour 2017 and the Waikato Sunrise Rotary have also enabled this research. Mr Winston McEwan (Plastic Surgeon and Principal Researcher) and Mr Ian Campbell (Breast Surgeon and Co-Researcher) also donate their time.