MedTrace Logo

Lymphedema After Gyneco-oncologic Treatment

NCT05469945 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Genital Neoplasm

Interventions

DEVICE

Compressive garments class II

Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.

Sponsors & Collaborators

  • University Hospital, Louvain

    collaborator UNKNOWN

  • Kom Op Tegen Kanker

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Chris Monten, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469945 on ClinicalTrials.gov