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

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ClinicalTrials.gov Identifier: NCT00604994
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : August 20, 2013
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

Tracking Information
First Submitted Date January 13, 2008
First Posted Date January 30, 2008
Last Update Posted Date August 20, 2013
Study Start Date June 2008
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2008)
  • Time of onset of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ]
  • Incidence of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ]
  • Point prevalence of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ]
  • Severity of lymphoedema after gynaecological cancer treatment. [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00604994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 29, 2008)
  • Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer. [ Time Frame: 2 years ]
  • Impact of risk factors on development of lymphoedema. [ Time Frame: 2 years ]
  • Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease. [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Official Title Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Brief Summary 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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with gynaecological conditons requiring treatment
Condition
  • Female Genital Diseases
  • Ovarian Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Vulval Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Malignant
    Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
  • Benign
    Patients without malignant gynaecological cancers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2013)
761
Original Estimated Enrollment
 (submitted: January 29, 2008)
1000
Actual Study Completion Date April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00604994
Other Study ID Numbers LEGS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Queensland Centre for Gynaecological Cancer
Study Sponsor Queensland Centre for Gynaecological Cancer
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
Investigators
Principal Investigator: Andreas Obermair, MD FRANZCOG CGO Queensland Centre for Gynaecological Cancer
PRS Account Queensland Centre for Gynaecological Cancer
Verification Date August 2013