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Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
Sponsor: Rigshospitalet, Denmark
Summary
The goal of this observational study is to examine the development and impact of lymphedema in men treated for prostate cancer. Lymphedema is swelling caused by damage to the lymphatic system and may develop after surgery with lymph node removal or after radiotherapy. The main questions it aims to answer are: How many men develop lower limb lymphedema after prostate cancer treatment? Which men are at highest risk of developing lymphedema? How does lymphedema affect quality of life? Participants will attend follow-up visits every three months for 18 months at one of three Danish hospital sites: Rigshospitalet, Herlev-Gentofte Hospital, or Zealand University Hospital. At each visit, participants will undergo examinations for signs of lymphedema and complete questionnaires about symptoms, quality of life, and daily functioning. Participants who develop signs of lymphedema during the study will be advised to seek assessment and treatment from the hospital's lymphedema therapist.
Official title: Addressing the Forgotten Sex in Lymphedema Research: Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
214
Start Date
2024-02-02
Completion Date
2026-10-31
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Radical Prostatectomy and Radiotherapy
Participants receive either radical prostatectomy with pelvic lymph node dissection or radiotherapy to the pelvic region as part of standard treatment for prostate cancer. Treatments are not assigned by the study.
Locations (3)
Rigshospitalet
Copenhagen, Denmark
Herlev and Gentofte Hospital
Herlev, Denmark
Zealand University Hospital
Roskilde, Denmark