Clinical trial NCT04579029: PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema
Official title: Prospective Randomized Evaluation of Lymphaticovenous Anastomosis Using Dynamic Imaging in Breast Cancer-related Lymphoedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lymphedema
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lymphoedema is a chronic debilitating disease that can have severe adverse effects on day-to-day life causing great physical and visual discomfort. The clinical presentation is characterised by chronic swelling of limbs, accompanied by localised pain, skin changes and recurrent infections. It is caused by a disruption in lymphatic flow which prevents the normal circulation of interstitial fluid (situated in the spaces between the cells of the body), resulting in swelling of the affected limb. It can be primary (cause unknown) or secondary to a number of causes such as malignancy, trauma, surgery, radiotherapy, infection, or venous disease.

In breast cancer treatment, axillary surgery and radiotherapy significantly damage normal lymphatic drainage of the upper limb, causing lymphoedema in 1-in-5 patients.

There is a growing body of evidence that this chronic and debilitating condition can be better managed through early surgical intervention rather than the current conservative management, which rely on pressure garments and massage. This surgical intervention, lymphaticovenous anastomosis (LVA), joins up a number of the draining lymphatic vessels to correspondingly sized veins on the affected limb using microsurgical techniques. A special dye and camera system is used to facilitate identifying lymph vessels. This creates a new drainage pathway for the lymph fluid around the area of disruption, improving lymphatic flow. Volume reduction is expected and this would be expected to provide quality of life benefits for the patients.

This study seeks to compare the outcomes from both therapies and determine whether LVA surgery can help to improve the physical burden and quality of life for patients affected by lymphoedema. Furthermore, lymphoedema places a substantial burden on NHS services. If this trial is successful, LVA surgery could improve patient outcomes and reduce the overall cost of treatment.


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

Primary outcomes:
measure: Mean excess volume reduction - compared between two cohorts
timeFrame: 12 months from recruitment
Secondary outcomes:
measure: Safety - infection and surgical complications
timeFrame: 12 months from recruitment
measure: Bio-impedance spectroscopy
timeFrame: 12 months from recruitment
measure: Cellulitis
timeFrame: 12 months from recruitment
measure: Quality of life - LYMQOL score
timeFrame: 12 months from recruitment
measure: Compliance
timeFrame: 12 months from recruitment
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Mark Brandon-Grove
state: Surrey
city: London
country: United Kingdom
facility: Mark Brandon-Grove
Study officials:
References: