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Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer (LEGS)
This study is currently recruiting participants.
Verified by Queensland Centre for Gynaecological Cancer, October 2008
Sponsors and Collaborators: Queensland Centre for Gynaecological Cancer
The University of Queensland
Royal Brisbane and Women's Hospital
Mater Adult Hospital and Mater Public Hospital
Queensland Institute of Medical Research
Queensland University of Technology
Information provided by: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00604994
  Purpose

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 and 2009.


Condition
Benign Gynaecological Diseases
Malignant Gynaecological Diseases

Genetics Home Reference related topics: lymphedema-distichiasis syndrome
MedlinePlus related topics: Cancer Lymphedema Reproductive Health
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Time of onset of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Point prevalence of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Severity of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Impact of risk factors on development of lymphoedema. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1000
Study Start Date: June 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Malignant gynaecological diseases
2
Benign gynaecological diseases.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospital clinics.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604994

Contacts
Contact: Linda Rogers +61 7 3636 2144 Linda_Rogers@health.qld.gov.au
Contact: Monika Janda, PhD +61 7 3138 9674 m.janda@qut.edu.au

Locations
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Andreas Obermair, MD FRANZCOG CGO     +61 7 3636 8501     andreas_obermair@health.qld.gov.au    
Contact: Linda Rogers     +61 7 3636 4343     Linda_Rogers@health.qld.gov.au    
Principal Investigator: Andreas Obermair, MD CGO            
Sub-Investigator: Jim Nicklin, MBBS CGO            
Sub-Investigator: Russell Land, PhD MBBS CGO            
Mater Public Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Lewis Perrin, MBBS CGO     +61 7 3399 6862     lewisperrin@mc.mater.org.au    
Contact: Linda Rogers     +61 7 3636 4343     Linda_Rogers@health.qld.gov.au    
Principal Investigator: Lewis Perrin, MBBS CGO            
Sub-Investigator: Alex Crandon, MBBS CGO            
Sub-Investigator: Marcello Nascimento            
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
The University of Queensland
Royal Brisbane and Women's Hospital
Mater Adult Hospital and Mater Public Hospital
Queensland Institute of Medical Research
Queensland University of Technology
Investigators
Principal Investigator: Andreas Obermair, MD FRANZCOG CGO Queensland Centre for Gynaecological Cancer
  More Information

Responsible Party: Queensland Centre for Gynaecological Cancer ( Professor Andreas Obermair )
Study ID Numbers: LEGS
Study First Received: January 13, 2008
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00604994  
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Queensland Centre for Gynaecological Cancer:
Lymphoedema
Gynaecology
Oncology
Malignant
Benign
Incidence

Study placed in the following topic categories:
Lymphedema
Genital Diseases, Female
Lymphatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009