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| ID | Type | Description | Link |
|---|---|---|---|
| R352-A20774 | Other Grant/Funding Number | Danish cancer society |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical Prostatectomy and Radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical Prostatectomy and Radiotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of lymphedema | Measured using multiple parameters, including bioimpedance spectroscopy, leg volume measurements, patient-reported symptoms, pitting, and clinical evaluation by a lymphedema therapist or physician. | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression using the Major Depression Inventory (MDI) | 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. | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
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Inclusion criteria
Exclusion criteria
• History of lymph node dissection/radiotherapy at the level of the pelvic or groin
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Herlev and Gentofte Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40518468 | Background | 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. | |
| 36428759 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Functioning, Disability and Health associated with lymphedema measured by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema |
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. |
| From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
| Quality of life measured by EORTC QLQ-C30 | 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. | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
| Urinary dysfunction and sexual function measured with the prostate cancer-specific subscale EORTC QLQ-PR25 | 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. | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
| Physical activity measured by International Physical Activity Questionnaire (IPAQ) | 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. | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. |
| Herlev |
| 2730 |
| Denmark |
| Zealand University Hospital | Roskilde | 4000 | Denmark |
| 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |