Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort (AWARE)
2026年6月11日 更新者：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.
研究概览
研究类型
观察性的
注册 (实际的)
214
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Copenhagen、丹麦、2100
- Rigshospitalet
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Herlev、丹麦、2730
- Herlev and Gentofte Hospital
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Roskilde、丹麦、4000
- Zealand University Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of lymphedema
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression using the Major Depression Inventory (MDI)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年2月2日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2026年10月31日
研究注册日期
首次提交
2026年5月19日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- AWARE
- R352-A20774 (其他赠款/资助编号：Danish cancer society)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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