Aalborg University Hospital
Aalborg, The North Denmark Region, Denmark
Location status: Recruiting
NCT Number: NCT07443618
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aalborg, The North Denmark Region, Denmark
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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):
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
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 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.
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.
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.
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.
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.
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.
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.
Based on spot urine
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.
Both oral, enteral and parenteral.
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.
Both oral, enteral and parenteral.
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.
Both oral, enteral and parenteral.
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.
Both oral, enteral and parenteral.
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.
Both oral, enteral and parenteral
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Based on blood sample
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.
Contact information is provided by the study sponsor or research team.
Emilie S Nør, Clinical Dietitian, Stud.MSc
CONTACT
Jens R Andersen, MD, MPA
CONTACT
Jens Rikardt Andersen
Other
Monitoring of Oedema in Cancer Patients - A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04397575
COVID, Cancer
Abbeville, France
View Trial DetailsNCT07175376
Cancer, Chemotherapy
Charlotte, North Carolina, United States
View Trial DetailsNCT02304913
Acupuncture, Cancer
Essen, North Rhine-Westphalia, Germany
View Trial DetailsNCT06809101
Cancer, Cancer-related Problem/Condition
Næstved, Region Sjælland, Denmark
View Trial Details