Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer (LEGS)
|ClinicalTrials.gov Identifier: NCT00604994|
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : August 20, 2013
|Condition or disease|
|Female Genital Diseases Ovarian Cancer Cervical Cancer Endometrial Cancer Vulval Cancer|
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:
- At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
- 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.
- 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.
- 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|
|Actual Enrollment :||761 participants|
|Observational Model:||Case Control|
|Official Title:||Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer|
|Study Start Date :||June 2008|
|Primary Completion Date :||January 2013|
|Study Completion Date :||April 2013|
Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
Patients without malignant gynaecological cancers
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604994
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Camperdown, New South Wales, Australia, 2050|
|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|
|Royal Women's Hospital|
|Carlton, Victoria, Australia, 3053|
|Principal Investigator:||Andreas Obermair, MD FRANZCOG CGO||Queensland Centre for Gynaecological Cancer|