Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort (AWARE)
11. juni 2026 oppdatert 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
214
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of lymphedema
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression using the Major Depression Inventory (MDI)
Tidsramme: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. februar 2024
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
31. oktober 2026
Datoer for studieregistrering
Først innsendt
19. mai 2026
Først innsendt som oppfylte QC-kriteriene
19. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Lymfesykdommer
- Hemic og lymfatiske sykdommer
- Prostatiske neoplasmer
- Lymfødem
- Terapeutikk
- Strålebehandling
Andre studie-ID-numre
- AWARE
- R352-A20774 (Annet stipend/finansieringsnummer: Danish cancer society)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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Nei
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