An observational study in Cancer, Oedema and Bioelectrical Impedance, sponsored by Jens Rikardt Andersen. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Jens Rikardt Andersen · Observational
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:
Participants will:
Both groups will undergo measurements over a maximum period of six days.
Outpatients:
Outpatients will complete three measurement cycles, each consisting of two consecutive days:
Each measurement cycle will be separated by a 7-14-day interval.
Hospitalized patients:
Hospitalized patients will undergo up to six consecutive measurement days, or until discharge or transfer to another ward:
If the treating physician administers i.v. loop diuretics to the hospitalized patient, additional measurements will be taken before administration and hourly for five hours thereafter, as these may significantly affect fluid levels.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 46 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Jens Rikardt Andersen is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.
Inclusion Criteria (Outpatient breast cancer patients with lymphoedema after radiotherapy):
Inclusion Criteria (Hospitalized cancer patients with peripheral oedema in one or both lower extremities after chemotherapy):
Exclusion Criteria (both groups):
Bio Impedance: ΔTotal body fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) and ΔPhase angle PhA (°)
Electrodes placed on hands/writs and feet/lower shins
Time frame: 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.
Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og ΔPhase angle PhA (°)
Electrodes placed close to the local oedema
Time frame: 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.
ΔBody weight (kg)
Time frame: 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.
ΔdU-urea (mmol/d)
Based on 24 h urine collection
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔdU-creatinine (mmol/d)
Based on 24 h urine collection
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔdU-sodium (mmol/d)
Based on 24 h urine collection
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔdU-potassium (mmol/d)
Based on 24 h urine collection
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔdU-chloride (mmol/d)
Based on 24 h urine collection
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔdU-pH
Based on spot urine
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔEnergy intake (kJ/kg/day)
Both oral, enteral and parenteral.
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔProtein intake (g/kg/day)
Both oral, enteral and parenteral.
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔSodium intake (mg/kg/day)
Both oral, enteral and parenteral.
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔPotassium intake (mg/kg/day)
Both oral, enteral and parenteral.
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔChloride intake (mg/kg/day)
Both oral, enteral and parenteral
Time frame: Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.
ΔPlasma colloid osmotic pressure (mmHg)
Based on blood sample
Time frame: 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.
ΔPlasma albumin (g/L)
Based on blood sample
Time frame: 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.
ΔBlood haemoglobin (g/L)
Based on blood sample
Time frame: 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.
ΔPlasma creatinine (micromoles per liter)
Based on blood sample
Time frame: 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.
ΔPlasma urea (mmol/L)
Based on blood sample
Time frame: 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.
ΔPlasma glucose (mmol/L)
Based on blood sample
Time frame: 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.
ΔBlood haematocrit (%)
Based on blood sample
Time frame: 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.
ΔPlasma CRP
Based on blood sample
Time frame: 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.
ΔBlood leucocytes
Based on blood sample
Time frame: 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.
Clinical palpatory assessment of oedema volume
Time frame: 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.
Plan to share: No — No individual participant data will be shared because the data are personal and sensitive.
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Jens Rikardt Andersen