Measuring Fluid Buildup in Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJens Rikardt Andersen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
46 Participants
are grouped into 2 trial groupsGroup A: Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy
Group B: Hospitalized cancer patients with oedema in leg/legs after chemotherapy
Trial outcomes
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
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.Secondary outcomes
1
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.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)
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jens Rikardt Andersen
Lead sponsor
University of Copenhagen
Sponsor institution
Aalborg University Hospital
Collaborator
University of Copenhagen
Collaborator
Source ClinicalTrials.gov