None listed
Conditions
Brief summary
Upper limb lymphoedema is a common and often distressing sequelae of breast cancer treatment. Reconstructive lymphatic microsurgery may be considered if conservative treatment fails but is highly specialised and expensive. This phase two, pragmatic, randomised 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.
Interventions
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 will have a minimum of five years experience. This surgery is carried out in one surgical procedure and takes approximately 60 minutes.
In this is a randomised controlled trial
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 will have a minimum of five years experience. This surgery is carried out in one surgical procedure and takes approximately 60 minutes. In this is a randomised controlled trial participants will be randomly assigned to; • The control group (standard care): Will receive standard lymphoedema therapy alone. This includes self-administered massage, therapeutic exercise, use of a compression sleeve and skin/nail care; OR • The intervention group: Will undergo lymph node grafting surgery as well as standard lymphoedema therapy. Adherence to the intervention won't be assessed. Standard lymphoedema therapy provided by Waikato lymphoedema therapists will be standardised.
Sponsors
Mr Winston McEwan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed