Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer (LEGS)
Sponsor: Australia New Zealand Gynaecological Oncology Group
Listed as NCT00604994, this observational or N/A phase trial focuses on Cervical Cancer and Endometrial Cancer and remains completed. Sponsored by Australia New Zealand Gynaecological Oncology Group, it has been updated 8 times since 2008, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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...
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed
-
Sep 2024 — Present [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
-
Jan 2021 — Jul 2024 [monthly]
Completed
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Oct 2019 — Jan 2021 [monthly]
Completed
▶ Show 3 earlier versions
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Jun 2018 — Oct 2019 [monthly]
Completed
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Apr 2018 — Jun 2018 [monthly]
Completed
Phase: NA → None
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Jan 2017 — Apr 2018 [monthly]
Completed NA
First recorded
Jun 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Australia New Zealand Gynaecological Oncology Group
- Cancer Australia
- Mater
- Mater Private Hospital
- Queensland Centre for Gynaecological Cancer
- Queensland Institute of Medical Research
- Queensland University of Technology
- Royal Brisbane and Women's Hospital
- The University of Queensland
For direct contact, visit the study record on ClinicalTrials.gov .