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NCT Number: NCT07443618

Measuring Fluid Buildup in Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, The North Denmark Region, Denmark

Location status: Recruiting

Location contact

Emilie S Nør

CONTACT

[email protected]

004520232289

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bio Impedance: ΔTotal body fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) and ΔPhase angle PhA (°)

    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.

    Electrodes placed on hands/writs and feet/lower shins

Secondary outcomes

  1. Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og ΔPhase angle PhA (°)

    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.

    Electrodes placed close to the local oedema

  2. 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.

  3. ΔdU-urea (mmol/d)

    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.

    Based on 24 h urine collection

  4. ΔdU-creatinine (mmol/d)

    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.

    Based on 24 h urine collection

  5. ΔdU-sodium (mmol/d)

    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.

    Based on 24 h urine collection

  6. ΔdU-potassium (mmol/d)

    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.

    Based on 24 h urine collection

  7. ΔdU-chloride (mmol/d)

    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.

    Based on 24 h urine collection

  8. ΔdU-pH

    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.

    Based on spot urine

  9. ΔEnergy intake (kJ/kg/day)

    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.

    Both oral, enteral and parenteral.

  10. ΔProtein intake (g/kg/day)

    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.

    Both oral, enteral and parenteral.

  11. ΔSodium intake (mg/kg/day)

    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.

    Both oral, enteral and parenteral.

  12. ΔPotassium intake (mg/kg/day)

    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.

    Both oral, enteral and parenteral.

  13. ΔChloride intake (mg/kg/day)

    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.

    Both oral, enteral and parenteral

  14. ΔPlasma colloid osmotic pressure (mmHg)

    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.

    Based on blood sample

  15. ΔPlasma albumin (g/L)

    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.

    Based on blood sample

  16. ΔBlood haemoglobin (g/L)

    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.

    Based on blood sample

  17. ΔPlasma creatinine (micromoles per liter)

    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.

    Based on blood sample

  18. ΔPlasma urea (mmol/L)

    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.

    Based on blood sample

  19. ΔPlasma glucose (mmol/L)

    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.

    Based on blood sample

  20. ΔBlood haematocrit (%)

    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.

    Based on blood sample

  21. ΔPlasma CRP

    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.

    Based on blood sample

  22. ΔBlood leucocytes

    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.

    Based on blood sample

  23. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie S Nør, Clinical Dietitian, Stud.MSc

CONTACT

[email protected]

004520232289

Jens R Andersen, MD, MPA

CONTACT

[email protected]

0045 23346654

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Collaborators

  • Aalborg University Hospital
  • University of Copenhagen

Registry information

Official study title

Monitoring of Oedema in Cancer Patients - A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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