PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema (PRELUDE)
Breast Cancer, Lymphedema
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Breast cancer patients treated with axillary surgery who have developed post-surgical lymphoedema (increase in limb volume by >10% for 1 month or longer)
- Patients must have completed their adjuvant therapy (excluding hormonal/long term Rx)
- Patients must be within 6 months of having developed documented lymphoedema
Exclusion Criteria:
• Contraindications to the use of the contrast agent (iodine allergy / untreated hypothyroidism)
- Near infra-red spectroscopy providing insufficient data to guide surgery or evidence of LVA incompatibility (As these patients will be have only just developed lymphoedema, they are by definition very early in the spectrum of disease progression. Thus, the chances of all superficial lymphatics deteriorating to the extent that LVA surgery is not possible is extremely low - <1% we expect).
- Inability to give informed consent or cooperate with assessment procedures and follow-up because of cognitive or physical impairments
- Medical co-morbidities increasing the risk of general anaesthetic (significant cardiac / respiratory disease)
- Recurrent, metastatic or progressive disease, defined by oncology team on basis of clinical assessment or imaging
- Evidence of pre-existing / primary lymphoedema on clinical history or lymphoscintigraphy
Sites / Locations
- Mark Brandon-GroveRecruiting
- Mark Brandon-GroveRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Surgical Cohort
Non-surgical cohort
Patients randomised to the surgical group will undergo near infrared spectroscopy imaging to assess suitability and plan the surgical procedure. Limb measurements with perometry and bio-impedance spectroscopy will be performed at baseline. Under general anaesthetic multiple LVA bypass procedures will be performed on the affected arm. Near infrared spectroscopy imaging will be used throughout. One week after discharge the patient will return for the bandages to be removed and the wounds inspected for any evidence of infection before renewing the bandage. Again, two weeks after surgery, the patient will return for inspection of wound and removal of sutures. It is at this point that the surgical patients will be returned into a standard lymphoedema compression garment, fitted by the research nurse. Thereafter, standard follow up (Bilateral) measurements and checks will be done at 1 month, 3 months, 6 months and 1 year.
The main intervention for the non-surgical group largely encompasses limb measurements with perometry and bio-impedance spectroscopy at baseline before a compression garment is applied. The compression garments will be measured and fitted by a trained lymphoedema specialist and will be given the standard advice as is best practice for such patients currently. This cohort will likewise be followed up at 1 month, 3 months, 6 months and 1 year and undergo perometry readings and measurements with comparable collection of data. For patients in both surgical and non-surgical groups, the compression garments will be measured and fitted by a trained lymphoedema specialist and they will be given the standard advice as is best practice for such patients currently. For each patient key details of the surgical technique, garment specification, imaging results and perometry/BIS measurements will be recorded on a study specific form for subsequent entry onto the database.