Measuring Fluid Buildup in Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Oedema, Bioelectrical Impedance, Lymphoedema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monitoring of Oedema in Cancer Patients - A Pilot Study
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aalborg University Hospital — Aalborg
Identifiers
NCT: NCT07443618 · N-20250028