CancerNCT07443618
Measuring Fluid Buildup in Cancer Patients
An observational study of Cancer and Oedema, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Oedema, Bioelectrical Impedance
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.
Who may be able to join
None listed.
Who cannot join
- 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.
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- Inability to cooperate with urine collection
- Receiving dialysis
- Terminal illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, The North Denmark Region
Emilie S Nør, 004520232289, e.noer@rn.dk
About this study
Official title: 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)
Read more
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.
Read the 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.
- Conditions
- Cancer, Oedema, Bioelectrical Impedance, Lymphoedema, Chemotherapy, Radiotherapy
- Keywords
- Localized oedema in cancer, Bioelectrical impedance, Post radiation lymphoedema
- Medical subject headings
- Neoplasms, Edema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy | Not described | |
| Hospitalized cancer patients with oedema in leg/legs after chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (°)
Electrodes placed close to the local oedema
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, University of Copenhagen
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, MD, MPA, Assoc Prof, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443618
- Sponsor's protocol ID
- N-20250028
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared because the data are personal and sensitive.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Oedema in Cancer Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT07443618
- Acronym / sponsor ID
- N-20250028
- Conditions
- Cancer, Oedema, Bioelectrical Impedance, Lymphoedema, Chemotherapy, Radiotherapy
- Keywords
- Localized oedema in cancer, Bioelectrical impedance, Post radiation lymphoedema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, University of Copenhagen
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy | – | – |
| Hospitalized cancer patients with oedema in leg/legs after chemotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
23 secondary outcomes
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.
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)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 (%)
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared because the data are personal and sensitive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens R Andersen, MD, MPA, Assoc Prof principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Oedema, run by Jens Rikardt Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie S Nør, Clinical Dietitian, Stud.MSc (004520232289, e.noer@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.