deltatrials
Completed OBSERVATIONAL NCT00604994

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

Sponsor: Australia New Zealand Gynaecological Oncology Group

Updated 8 times since 2017 Last updated: Aug 18, 2013 Started: Jun 30, 2008 Primary completion: Jan 31, 2013 Completion: Apr 30, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2019 · 16 months · monthly snapshotCompleted~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. Oct 2019 — Jan 2021 [monthly]

    Completed

Show 3 earlier versions
  1. Jun 2018 — Oct 2019 [monthly]

    Completed

  2. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  3. 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

Sponsor contact:
  • 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
Data source: Queensland Centre for Gynaecological Cancer

For direct contact, visit the study record on ClinicalTrials.gov .