Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

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Brief Title

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Official Title

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

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.
    


Study Type

Observational


Primary Outcome

Time of onset of lymphoedema after gynaecological cancer treatment.

Secondary Outcome

 Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.

Condition

Female Genital Diseases


Study Arms / Comparison Groups

 Malignant
Description:  Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

761

Start Date

June 2008

Completion Date

April 2013

Primary Completion Date

January 2013

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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andreas Obermair, MD FRANZCOG CGO, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00604994

Organization ID

LEGS


Responsible Party

Sponsor

Study Sponsor

Queensland Centre for Gynaecological Cancer

Collaborators

 The University of Queensland

Study Sponsor

Andreas Obermair, MD FRANZCOG CGO, Principal Investigator, Queensland Centre for Gynaecological Cancer


Verification Date

August 2013