Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:02 AM
Study NCT ID:
NCT07443618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Fluid Buildup in Cancer Patients
Sponsor:
Jens Rikardt Andersen
Organization:
Study Overview
Official Title:
Monitoring of Oedema in Cancer Patients - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: