NCT07443618 Measuring Fluid Buildup in Cancer Patients
| NCT ID | NCT07443618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jens Rikardt Andersen |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 46 participants in total. It began in 2026-02-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jens R Andersen, MD, MPA, Assoc Prof
PRINCIPAL INVESTIGATOR
University of Copenhagen
Frequently Asked Questions
Who can join the NCT07443618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443618 currently recruiting?
Yes, NCT07443618 is actively recruiting participants. Contact the research team at e.noer@rn.dk for enrollment information.
Where is the NCT07443618 trial being conducted?
This trial is being conducted at Aalborg, Denmark.
Who is sponsoring the NCT07443618 clinical trial?
NCT07443618 is sponsored by Jens Rikardt Andersen. The principal investigator is Jens R Andersen, MD, MPA, Assoc Prof at University of Copenhagen. The trial plans to enroll 46 participants.
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