Lymphedema After Gyneco-oncologic Treatment

Sponsor
University Hospital, Ghent
Study ID
NCT05469945
Status
Recruiting
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Conditions

  • Genital Neoplasm
  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Compressive garments class II — DEVICE
    Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.

Study Details

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.

Key Dates

First listed
Jul 22, 2022
Start date
Jun 22, 2022
Status verified
Jun 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control arm: no compressive garments
    Patients detected with early stage LLL (0-1 ISL stadia) start with education and preventive measures.
  • Experimental: Interventional arm: start of CC2 compressive garments
    Patients in the experimental arm and detected with early stage LLL (0-1 ISL stadia) start with CC2 compressive garments in addition to education and preventive measures.

Primary Outcome Measure

Incidence rate of LLL [ Time Frame: From diagnosis until 2 years after last oncologic treatment ]

Central Contacts

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