Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Ghent University Hospital, Dept. Radiotherapy-Oncology
RECRUITING
Ghent
University Hospital, Louvain
RECRUITING
Leuven
Contact Information
Primary
Chris Monten, MD, PhD
chris.monten@uzgent.be
093320749
Backup
Caren Randon, MD, PhD
caren.randon@uzgent.be
093326252
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 218
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Louvain, Kom Op Tegen Kanker
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov