Lower Limb Lymphedema, Prostate Cancer
Conditions
Keywords
Prostate cancer, Lower Limb Lymphedema, Lymphedema, Health-related quality of life
Brief 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.
Interventions
OTHERRadical Prostatectomy and Radiotherapy
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.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of lymphedema | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. | Measured using multiple parameters, including bioimpedance spectroscopy, leg volume measurements, patient-reported symptoms, pitting, and clinical evaluation by a lymphedema therapist or physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression using the Major Depression Inventory (MDI) | 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. |
| Functioning, Disability and Health associated with lymphedema measured by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema | 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. |
| Quality of life measured by EORTC QLQ-C30 | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. | 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. |
| Urinary dysfunction and sexual function measured with the prostate cancer-specific subscale EORTC QLQ-PR25 | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. | 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. |
| Physical activity measured by International Physical Activity Questionnaire (IPAQ) | From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months. | 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. |
Countries
Denmark
Outcome results
None listed