No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
218 (estimated)
Sponsor
University Hospital, Ghent · Other
Who this trial is looking for
This trial is looking for women who have been recently diagnosed with gynecologic cancer and are starting treatment. Participants will help researchers understand the risk of developing lymphedema in their legs after treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with gynecologic cancer.
I am female.
I am at least 18 years old.
I understand the Dutch language.
I am willing to participate in the study and complete questionnaires.
You may not be able to join if
I have had treatment for gynecologic cancer before.
I have another type of cancer at the same time.
I am pregnant or planning to get pregnant within the next 2 years.
I have known cancer that has spread at the time of joining.
I have had severe injury or surgery on my legs or groin in the past.
I have circulation problems in my leg that have not been treated.
I have mental or psychological problems that prevent me from participating.
I started my first treatment more than 2 weeks ago.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 lymp…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Able to understand the informed consent and …
Inclusion Criteria:
* 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
* Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires.
Exclusion Criteria:
* 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)
* Severe injury, surgery or deformation of the legs or groins in the past
* Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more)
* Mental or psychological problems, inability to comply to the study protocol
* First treatment administered \> 2 weeks before
* Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
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