Ovarian Cancer Clinical Trial
Official title:
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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