Measuring Fluid Buildup in Cancer Patients

NCT07443618 | Recruiting

• 1 other identifier: N-20250028
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Balance; Cancer; Oedema; Bioelectrical Impedance; Lymphoedema; Chemotherapy; Radiotherapy

Keywords

Localized oedema in cancer; Bioelectrical impedance; Post radiation lymphoedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

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

  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)

  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)

  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)

  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.

Study Arms (2)

Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy

Hospitalized cancer patients with oedema in leg/legs after chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Rikardt Andersen: lead
• Aalborg University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, The North Denmark Region, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma and urine.

MeSH Terms

Conditions

Neoplasms; Edema; Lymphedema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jens R Andersen, MD, MPA, Assoc Prof

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie S Nør, Clinical Dietitian, Stud.MSc

CONTACT

004520232289; e.noer@rn.dk

Jens R Andersen, MD, MPA

CONTACT

0045 23346654; jra@nexs.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Emeritus

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)