Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Ovarian Cancer Clinical Trial

— LEGS  

Official title:

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604994
• Other study ID #: LEGS
• Status: Completed
• Phase: N/A
• First received: January 13, 2008
• Last updated: August 18, 2013
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Female Genital Diseases
• Genital Diseases, Female
• Lymphedema
• Ovarian Cancer
• Uterine Cervical Neoplasms
• Vulval Cancer
• Vulvar Neoplasms

Locations

Country	Name	City	State
Australia	The Wesley Hospital	Auchenflower	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Royal Women's Hospital	Carlton	Victoria
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Mater Health Services	South Brisbane	Queensland

Sponsors (9)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer	Australia New Zealand Gynaecological Oncology Group, Cancer Australia, Mater Health Services, Brisbane, Mater Private Hospital, Queensland Institute of Medical Research, Queensland University of Technology, Royal Brisbane and Women's Hospital, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of onset of lymphoedema after gynaecological cancer treatment.		2 years	No
Primary	Incidence of lymphoedema after gynaecological cancer treatment.		2 years	No
Primary	Point prevalence of lymphoedema after gynaecological cancer treatment.		2 years	No
Primary	Severity of lymphoedema after gynaecological cancer treatment.		2 years	No
Secondary	Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.		2 years	No
Secondary	Impact of risk factors on development of lymphoedema.		2 years	No
Secondary	Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.		2 years	No

External Links

•   QCGC Research