Clinical trial NCT00604994: Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Official title: Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Genital Diseases
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Vulval Cancer
Keywords: Lymphoedema
Gynaecology
Oncology
Malignant
Benign
Incidence
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
Collaborators: name: The University of Queensland
name: Royal Brisbane and Women's Hospital
name: Mater
name: Mater Private Hospital
name: Queensland Institute of Medical Research
name: Queensland University of Technology
name: Australia New Zealand Gynaecological Oncology Group
name: Cancer Australia
First posted: 2008-01-30
Enrollment: 761
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with gynaecological conditons requiring treatment

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time of onset of lymphoedema after gynaecological cancer treatment.
timeFrame: 2 years
measure: Incidence of lymphoedema after gynaecological cancer treatment.
timeFrame: 2 years
measure: Point prevalence of lymphoedema after gynaecological cancer treatment.
timeFrame: 2 years
measure: Severity of lymphoedema after gynaecological cancer treatment.
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.
timeFrame: 2 years
measure: Impact of risk factors on development of lymphoedema.
timeFrame: 2 years
measure: Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.
timeFrame: 2 years
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: The Wesley Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Carlton
country: Australia
facility: Royal Women's Hospital
state: Victoria
Study officials:
affiliation: Queensland Centre for Gynaecological Cancer
name: Andreas Obermair, MD FRANZCOG CGO
role: PRINCIPAL_INVESTIGATOR
References: