Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer (LEGS)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Ovarian Cancer; Endometrial Cancer; Female Genital Diseases; Vulval Cancer

Detailed Description

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:

1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
2. 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.
3. 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.
4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

• Study Type: Observational
• Enrollment (Actual): 761

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • The Wesley Hospital
    • Greenslopes, Queensland, Australia, 4120
      • Greenslopes Private Hospital
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Health Services
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Royal Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with gynaecological conditons requiring treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Malignant; Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
Benign; Patients without malignant gynaecological cancers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of onset of lymphoedema after gynaecological cancer treatment.	2 years
Incidence of lymphoedema after gynaecological cancer treatment.	2 years
Point prevalence of lymphoedema after gynaecological cancer treatment.	2 years
Severity of lymphoedema after gynaecological cancer treatment.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.	2 years
Impact of risk factors on development of lymphoedema.	2 years
Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.	2 years

Collaborators and Investigators

• Sponsor: Queensland Centre for Gynaecological Cancer
• Collaborators: Royal Brisbane and Women's Hospital; The University of Queensland; Queensland University of Technology; Cancer Australia; Queensland Institute of Medical Research; Australia New Zealand Gynaecological Oncology Group; Mater; Mater Private Hospital
• Investigators: Principal Investigator: Andreas Obermair, MD FRANZCOG CGO, Queensland Centre for Gynaecological Cancer

Publications and helpful links

Helpful Links

• QCGC Research

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 13, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 18, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Incidence; Oncology; Malignant; Benign; Gynaecology; Lymphoedema
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Lymphedema; Endometrial Neoplasms
• Other Study ID Numbers: LEGS