Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort (AWARE)
11 juni 2026 uppdaterad av: Bolette Rafn, Rigshospitalet, Denmark
Addressing the Forgotten Sex in Lymphedema Research: Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
214
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Herlev, Danmark, 2730
- Herlev and Gentofte Hospital
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Roskilde, Danmark, 4000
- Zealand University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Men with prostate cancer receiving radical prostatectomy with pelvic lymph node dissection or radiotherapy at three urological departments in Eastern Denmark: Rigshospitalet, Herlev-Gentofte Hospital, and Zealand University Hospital.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Radical Prostatectomy and Radiotherapy
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of lymphedema
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Measured using multiple parameters, including bioimpedance spectroscopy, leg volume measurements, patient-reported symptoms, pitting, and clinical evaluation by a lymphedema therapist or physician.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression using the Major Depression Inventory (MDI)
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Depressive symptoms will be assessed using the Major Depression Inventory (MDI).
The MDI total score ranges from 0 to 50, with higher scores indicating more severe depressive symptoms.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
|
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Functioning, Disability and Health associated with lymphedema measured by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
|
Lymphedema-related functioning, disability, and health will be assessed using the Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL).
Scores range from 0 to 100, with higher scores indicating greater impairments in function, activity limitations, and participation restrictions related to lower limb lymphedema.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Quality of life measured by EORTC QLQ-C30
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Scores are transformed to a 0-100 scale.
For global health status and functioning scales, higher scores indicate better health-related quality of life or functioning.
For symptom scales/items, higher scores indicate greater symptom burden.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Urinary dysfunction and sexual function measured with the prostate cancer-specific subscale EORTC QLQ-PR25
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Prostate cancer-specific symptoms and functioning, including urinary symptoms and sexual function, will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25).
Scores are transformed to a 0-100 scale.
For symptom scales/items, higher scores indicate greater symptom burden.
For functioning scales, higher scores indicate better functioning.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
|
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Physical activity measured by International Physical Activity Questionnaire (IPAQ)
Tidsram: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ).
Physical activity will be reported as MET-minutes per week, with higher scores indicating higher levels of physical activity.
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From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Jensen S, Roder A, Hayes S, Larsen GS, Fode M, Ostergren PB, Al-Hamadani MMN, Johansen C, Rafn BS. Comprehensive assessment of lower limb edema and its association with quality of life among men with prostate cancer. Support Care Cancer. 2025 Jun 16;33(7):586. doi: 10.1007/s00520-025-09613-4.
- Clinckaert A, Callens K, Cooreman A, Bijnens A, Moris L, Van Calster C, Geraerts I, Joniau S, Everaerts W. The Prevalence of Lower Limb and Genital Lymphedema after Prostate Cancer Treatment: A Systematic Review. Cancers (Basel). 2022 Nov 18;14(22):5667. doi: 10.3390/cancers14225667.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 februari 2024
Primärt slutförande (Beräknad)
31 oktober 2026
Avslutad studie (Beräknad)
31 oktober 2026
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
19 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Lymfatiska sjukdomar
- Hemiska och lymfsjukdomar
- Prostatiska neoplasmer
- Lymfödem
- Terapeutik
- Strålbehandling
Andra studie-ID-nummer
- AWARE
- R352-A20774 (Annat bidrag/finansieringsnummer: Danish cancer society)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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