Lymphedema after gynaecological cancer

GynoLymph

Lower limb lymphedema after gynaeco-oncologic therapy: can we prevent irreversible lymphedema?

Most studies on lymphedema are limited to upper limb lymphedema, mainly after breast cancer treatment. Only few publications focus on lower limb lymphedema (LLL), despite its detrimental impact on QoL. This could be due to the difficulties to diagnose and treat LLL in comparison to ULL: LLL often occurs bilaterally or at the level of the groins or genital region, hence impeding diagnosis through comparison. Perimetric measurement of large cone-like edematous legs is cumbersome. Lymph drainage and application of compressive garments is more strenuous for legs than for arms, and the typical bilateral occurrence and large volumes of LLL inflate the cost of treatment garments. The low appeal of gynae-oncologic cancer in contrast to breast cancer is just another hurdle to overcome for trial development and funding in this area.

As thus, little evidence exists on diagnostic techniques for detection of early LLL and on early intervention intended to avoid progression to a consolidated advanced stage LLL. To obtain an answer to these questions, this observational cohort trial will follow women diagnosed with gynae-oncologic cancer from the start of their cancer treatment. To evaluate the added value of lymphedema detection-questionnaires and of non-invasive diagnostic measurements, these will be compared to lymphoscintigraphy, which is the gold standard for diagnosing lymphedema.

ICG-lymphography is a new technique to visualize on an anatomic level the subcutaneous lymphatic flow. It’s role in early mapping of lymphatic insufficiency in the legs will be evaluated by comparing early patient-reported signalling of symptoms related to lymphedema to this exam and to lymphoscintigraphy.

The role of highly compressive stockings (compression class 3-4) is well established in advanced lymphedema. In this irreversible stage, the inconvenience of wearing such garments is well balanced against the burden of lymphedema. In early stage lymphedema, compressive garments may prevent aggravation, but their need is less translated into daily well-being. Class II compression may suffice to avoid progression through lymphatic damage, but this has thus far not been studied. Moreover, class II compression for lymphedema prevention is not reimbursed in Belgium. To evaluate the added value of class II compression garments in preventing worsening of LLL, patients who present with early symptoms (stages 0 and 1 LLL) will be randomized to either education and prevention only or to a combination with class II compressive garments.

Cost-effectiveness of this early intervention will be based on an inventory of patient- and society-related expenses in combination with the lymphedema-reduction-effect and QoL.

The aim of this project can therefore be summarised in the following four research questions:
- What are the risk factors for development of lymphedema?
- How often and at which moment does lymphedema occur, after treatment for a gynaecological cancer?
- Can non-invasive tests such as self-evaluation, questionnaires, circumference measurement, measurement of fluid accumulation and ICG lymphofluoroscopy play a role in the early detection of lymphedema?
- Can early initiation of compressive leg stockings prevent aggravation of early reversible lymphedema to a severe irreversible stage?

> CarEdOn primary researchers: Prof. Nele Devoogdt, dr. Tessa De Vrieze

> Research partners: Dr. Chris Monten (PI), prof. Caren Randon, mrs. Vickie Van Besien, mrs. Mieke Deschryver, dr. Tina Decorte, UZ Gent (Belgium); prof. Nele Devoogdt, dr. Tessa De Vrieze, dpt of rehabilitation sciences, KU Leuven (Belgium)

> Keywords: secondary edema, compression therapy, edema, near-infrared fluorescence imaging

> Contact: nele.devoogdt@kuleuven.be; tessa.devrieze@kuleuven.be

With the support of Kom Op Tegen Kanker

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Status
In preparation
Starting date
01/06/2021
Status reference