Lymphedema After Gyneco-oncologic Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity Hospital, Ghent

About this trial

Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer.

Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment.

Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment.

Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.

Eligibility criteria

Qualifiers

Signed informed consent (ICF)

Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment

Age ≥ 18 years

Understanding of the Dutch language

Disqualifiers

History of treatment for gynaecologic cancer

Concurrent second primary tumor(s)

Pregnancy or pregnancy planned within 2 years

Known metastasized cancer at the time of inclusion (D0)

Trial design

Treatments tested in this trial

  • Compressive garments class II

Treatment groups

218 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Ghent

Lead sponsor

University Hospital, Louvain

Collaborator

Kom Op Tegen Kanker

Collaborator