Measuring Fluid Buildup in Cancer Patients

Monitoring of Oedema in Cancer Patients - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Chemotherapy; Radiotherapy; Oedema; Lymphoedema; Fluid Balance; Bioelectrical Impedance

Detailed Description

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:

• Day 1: Home-based dietary and fluid intake registration and 24-h urine collection
• Day 2: Hospital-based assessment including bioelectrical impedance analysis (BIA), blood sampling, body weight measurement, and clinical palpatory assessment

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:

• Days 1, 3, and 5: Dietary and fluid intake registration and 24-h urine collection
• Days 2, 4, and 6: Bioelectrical impedance analysis (BIA), blood sampling, body weight measurement, and clinical palpatory assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Emilie S Nør, Clinical Dietitian, Stud.MSc; Phone Number: 004520232289; Email: e.noer@rn.dk
• Study Contact Backup: Name: Jens R Andersen, MD, MPA; Phone Number: 0045 23346654; Email: jra@nexs.ku.dk

Study Locations

• Denmark
  • The North Denmark Region
    • Aalborg, The North Denmark Region, Denmark
      • Recruiting
      • Aalborg University Hospital
      • Contact: Emilie S Nør; Phone Number: 004520232289; Email: e.noer@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy
Hospitalized cancer patients with oedema in leg/legs after chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og ΔPhase angle PhA (°)	Electrodes placed close to the local oedema	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)		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	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	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	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	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	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	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.	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.	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.	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.	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	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	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	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	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	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	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	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	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	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	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		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.

Collaborators and Investigators

• Sponsor: Jens Rikardt Andersen
• Collaborators: University of Copenhagen; Aalborg University Hospital
• Investigators: Principal Investigator: Jens R Andersen, MD, MPA, Assoc Prof, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bioelectrical impedance; Localized oedema in cancer; Post radiation lymphoedema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Neoplasms; Lymphedema; Edema
• Other Study ID Numbers: N-20250028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared because the data are personal and sensitive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No