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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
| University of Copenhagen | OTHER |
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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:
Participants will:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy | |||
| Hospitalized cancer patients with oedema in leg/legs after chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og ΔPhase angle PhA (°) | Electrodes placed close to the local oedema | 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) |
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Inclusion Criteria (Outpatient breast cancer patients with lymphoedema after radiotherapy):
Inclusion Criteria (Hospitalized cancer patients with peripheral oedema in one or both lower extremities after chemotherapy):
Exclusion Criteria (both groups):
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The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jens R Andersen, MD, MPA, Assoc Prof | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | The North Denmark Region | Denmark |
No individual participant data will be shared because the data are personal and sensitive.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004487 | Edema |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Whole blood, plasma and urine.
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |