Actively Recruiting
Monitoring of Edema in Cancer Patients Using Bioelectrical Impedance Analysis - A Pilot Observational Study
Led by Jens Rikardt Andersen · Updated on 2026-04-29
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jens Rikardt Andersen
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether segmental bioelectrical impedance analysis (BIA) can effectively monitor local fluid retention, or edema, in cancer patients. The study includes two groups: breast cancer patients with lymphoedema in one or both arms after radiotherapy, and hospitalized cancer patients with fluid retention in one or both legs after chemotherapy. This observational study aims to improve how fluid buildup is tracked in these patients. Participants will undergo a series of measurements over a maximum of six days. Outpatients will complete three cycles of two consecutive days each, with home-based diet and fluid intake records and urine collection on the first day, followed by hospital assessments including BIA, blood sampling, weight measurement, and clinical palpation on the second day. Hospitalized patients will have up to six consecutive measurement days involving alternating days of diet/urine collection and clinical assessments. Additional measurements are taken around intravenous loop diuretic treatments if administered. During the study, participants will have their fluid levels, body weight, blood and urine markers, and edema volume assessed repeatedly. Data on diet, fluid intake, and various blood and urine parameters will be collected to understand fluid balance changes. The main outcome is change in total body fluid volume measured by BIA. Safety is ensured by excluding participants with conditions that could interfere with assessments. The overall participation duration varies but includes detailed monitoring over days or weeks depending on the group.
CONDITIONS
Brief Title
Measuring Fluid Buildup in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and speak Danish
- Age 18 years or older
- For outpatients: Received or receiving radiotherapy for breast cancer within the last 6 months
- For outpatients: Visible lymphoedema in at least one arm
- For outpatients: Receiving follow-up at the Oncology Outpatient Clinic
- For hospitalized patients: Received or receiving chemotherapy within the last 2 months
- For hospitalized patients: Visible peripheral oedema in at least one leg
- For hospitalized patients: Hospitalized in Oncology Ward with expected stay of at least 6 days
You will not qualify if you...
- Pregnant or breastfeeding
- Amputated limbs
- Pacemaker or implanted cardioverter-defibrillator
- Metallic prostheses
- Unable to lie still for a minimum of 2 minutes
- Unable to stand on a scale (permanently bedridden)
- Unable to cooperate with urine collection
- Receiving dialysis treatment
- Terminal illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 days for hospitalized patients or up to 6 weeks for outpatients with intervals
Participants undergo measurement cycles to monitor fluid buildup and edema using bioelectrical impedance analysis, blood sampling, dietary and fluid intake registration, urine collection, body weight measurement, and clinical palpatory assessment.
For outpatients: 3 measurement cycles, each with 1 home-based day and 1 hospital-based day separated by 7 to 14 days; For hospitalized patients: daily measurements up to 6 consecutive days
Trial Site Locations
Total: 1 location
1
Aalborg University Hospital
Aalborg, The North Denmark Region, Denmark
Actively Recruiting
Research Team
E
Emilie S Nør, Clinical Dietitian, Stud.MSc
J
Jens R Andersen, MD, MPA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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