Measuring Fluid Buildup in Cancer Patients (NCT07443618) | Clinical Trial Compass
RecruitingNot Applicable
Measuring Fluid Buildup in Cancer Patients
Denmark46 participantsStarted 2026-02-01
Plain-language summary
The goal of this study is to improve the monitoring of fluid retention in cancer patients. The main question it aims to answer is: Can segmental bioelectrical impedance analysis be used to monitor local fluid retention (edema) in cancer patients? We will include:
* Breast cancer patients with fluid and or lymph retention in one or both arms after radiotherapy (outpatients)
* Cancer patients with fluid retention in one or both legs after chemotherapy (hospitalized)
Participants will:
* Have measurements taken using bioelectrical impedance
* Provide blood samples and 24-hour urine collection
* Weight monitorering
* Complete diet and fluid registration (inclusive enteral and parenteral)
* Have clinical palpatory and measurement assessment of oedema.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Outpatient breast cancer patients with lymphoedema after radiotherapy):
* Habile
* Must be able to speak and read Danish
* Has received/is receiving radiotherapy due to breast cancer within the last 6 months
* Is being followed in the Oncology Outpatient Clinic at Aalborg University Hospital
* Age ≥ 18 years
* Visible lymphoedema in at least one upper extremity
Inclusion Criteria (Hospitalized cancer patients with peripheral oedema in one or both lower extremities after chemotherapy):
* Habile
* Must be able to speak and read Danish
* Has received/is receiving chemotherapy due to cancer within the last 2 months
* Hospitalised in the Oncology Ward at Aalborg University Hospital
* Estimated length of hospital stay of at least 6 days
* Age ≥ 18 years
* Visible peripheral oedema in at least one lower extremity
Exclusion Criteria (both groups):
* Pregnant or breastfeeding women
* Amputated limb(s)
* Pacemaker or implanted cardioverter-defibrillator due to risk of interference from the electrical signal
* Metallic prostheses due to risk of interference with the device signal
* Inability to lie still for the duration of the measurement interval (minimum 2 minutes at a time)
* Inability to stand on a scale, i.e. permanently bedridden.
* Inability to cooperate with urine collection
* Receiving dialysis
* Terminal illness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bio Impedance: ΔTotal body fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) and ΔPhase angle PhA (°)
Timeframe: Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.