Clinical trial · Observational
Measuring Fluid Buildup in Cancer Patients
Monitoring of Oedema in Cancer Patients - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bioelectrical Impedance | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy | — | UNRESOLVED | — |
| Fluid Balance | — | UNRESOLVED | — |
| Lymphoedema | — | UNRESOLVED | — |
| Oedema | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy
- label
- Hospitalized cancer patients with oedema in leg/legs after chemotherapy
Primary outcomes (1)
- measure
- 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.
- description
- Electrodes placed on hands/writs and feet/lower shins
Secondary outcomes (23)
- measure
- Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available