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Completed

NCT Number: NCT00604994

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

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Key information

About this study

Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.

The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.

The following hypotheses will be tested to address the aims of the project:

  • At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
  • Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
  • Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual & financial well-being, compared to those who do not develop lymphoedema.
  • There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient.
  • Non-pregnant female patients.
  • Over 18 years of age at time of surgery.
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
  • Patients who are capable of, and have given, informed consent to their participation in the study.

Exclusion criteria

  • Patients with a pacemaker.
  • Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.

Treatment and study plan

Primary outcomes

  1. Time of onset of lymphoedema after gynaecological cancer treatment.

    Time frame: 2 years

  2. Incidence of lymphoedema after gynaecological cancer treatment.

    Time frame: 2 years

  3. Point prevalence of lymphoedema after gynaecological cancer treatment.

    Time frame: 2 years

  4. Severity of lymphoedema after gynaecological cancer treatment.

    Time frame: 2 years

Secondary outcomes

  1. Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.

    Time frame: 2 years

  2. Impact of risk factors on development of lymphoedema.

    Time frame: 2 years

  3. Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Collaborators

  • Australia New Zealand Gynaecological Oncology Group
  • Cancer Australia
  • Mater
  • Mater Private Hospital
  • Queensland Institute of Medical Research
  • Queensland University of Technology
  • Royal Brisbane and Women's Hospital
  • The University of Queensland

Registry information

Acronym: LEGS

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2008
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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