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

This study has been completed.
Sponsor:
Collaborators:
The University of Queensland
Royal Brisbane and Women's Hospital
Mater Health Services, Brisbane
Mater Private Hospital
Queensland Institute of Medical Research
Queensland University of Technology
Australia New Zealand Gynaecological Oncology Group
Cancer Australia
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00604994
First received: January 13, 2008
Last updated: August 18, 2013
Last verified: August 2013
  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 to 2011.


Condition
Female Genital Diseases
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Vulval Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Resource links provided by NLM:


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 ]

Enrollment: 761
Study Start Date: June 2008
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Malignant
Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
Benign
Patients without malignant gynaecological cancers

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:   Non-Probability Sample
Study Population

Women with gynaecological conditons requiring treatment

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Health Services
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Royal Women's Hospital
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
The University of Queensland
Royal Brisbane and Women's Hospital
Mater Health Services, Brisbane
Mater Private Hospital
Queensland Institute of Medical Research
Queensland University of Technology
Australia New Zealand Gynaecological Oncology Group
Cancer Australia
Investigators
Principal Investigator: Andreas Obermair, MD FRANZCOG CGO Queensland Centre for Gynaecological Cancer
  More Information

Additional Information:
No publications provided

Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00604994     History of Changes
Other Study ID Numbers: LEGS
Study First Received: January 13, 2008
Last Updated: August 18, 2013
Health Authority: Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Genital Diseases, Female
Uterine Cervical Neoplasms
Ovarian Neoplasms
Lymphedema
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Lymphatic Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on September 22, 2014