Lymph node grafting for breast cancer related lymphoedema - Clinical trial • Breast Cancer Foundation NZ

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Lymph node grafting for breast cancer related lymphoedema

Screening, prevention, familial and other clinical trials for ER+

Recruiting
Updated: July 23, 2019

This phase 2 clinical trial is looking into lymph node grafting for upper limb lymphoedema following breast cancer treatment.

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.

This phase two, pragmatic, randomized controlled trial will compare a novel surgical technique; lymph node grafting (LNG) in addition to standard lymphoedema therapy, against standard lymphoedema therapy alone. Study participants will be those with residual stage one to two breast-cancer related lymphoedema despite initial treatment with standard lymphoedema therapy.

The aim is to determine whether LNG plus standard lymphoedema therapy produces a greater reduction in lymphoedema volume (LV) and improved quality of life compared with the control group; standard lymphoedema therapy alone. A further aim is to demonstrate that LNG is a safe treatment, with acceptable surgical morbidity.

The procedure itself 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 local anaesthetic. Lymph nodes are then grafted into the subcutaneous tissue of the elbow and wrist of the affected limb. Surgeons will have a minimum of five years experience. This surgery is carried out in one surgical procedure and takes approximately 60 minutes.

Key inclusion criteria

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

Key exclusion criteria

  • Metastatic 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)
  • Steroid medication

For full trial information

New Zealand

Waikato Hospital

Contact:

Heather Flay

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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