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NCT07607431
Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
Conditions: Prostate Cancer, Lower Limb Lymphedema
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 214
Sponsor: Rigshospitalet, Denmark
Location: Rigshospitalet Copenhagen
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.
Eligibility Criteria
Inclusion criteria
* Age ≥18 years
* Men diagnosed with any stage prostate cancer
* Planned prostatectomy with lymph node removal or radiotherapy
* Able to understand Danish
Exclusion criteria
• History of lymph node dissection/radiotherapy at the level of the pelvic or groin
Source: ClinicalTrials.gov (NCT07607431). StuddyBuddy aggregates publicly available trial information.