Tracking fluid buildup (edema) in people with cancer
Monitoring of Oedema in Cancer Patients - A Pilot Study
This will try segmental bioelectrical impedance analysis to see if it can monitor local fluid buildup in cancer patients who have arm or leg swelling after radiotherapy or chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aalborg, The North Denmark Region) |
| Trial ID | NCT07443618 on ClinicalTrials.gov |
What this trial studies
The study enrolls two groups—outpatients with arm lymphoedema after breast radiotherapy and hospitalized cancer patients with leg oedema after chemotherapy—and collects repeated measurements over several days. Measurements include segmental bioelectrical impedance analysis (BIA), blood sampling, 24-hour urine collection, body weight, diet and fluid intake logs, and clinical palpatory assessment. Outpatients complete three two-day measurement cycles separated by 7–14 days, while hospitalized patients undergo up to six consecutive measurement days with alternating measurement and collection days. If hospitalized patients receive IV loop diuretics, extra BIA and clinical measurements are taken before and hourly for five hours after administration.
Who should consider this trial
Good fit: Adults (≥18) who read and speak Danish and have visible lymphoedema in at least one arm within 6 months after breast radiotherapy (outpatients followed at Aalborg) or visible peripheral leg oedema within 2 months after chemotherapy while hospitalized in the Oncology Ward are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have amputated limbs, have implanted pacemakers/ICDs, cannot read or speak Danish, or are not treated/admitted at Aalborg University Hospital are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a simple, noninvasive way to detect and track local fluid retention so treatments can be timed and adjusted more effectively.
How similar studies have performed: Similar applications of bioelectrical impedance for lymphedema and localized oedema have shown promising but mixed results in small studies, so the method is plausible but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg, The North Denmark Region
- Aalborg University Hospital — Aalborg, The North Denmark Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens R Andersen, MD, MPA, Assoc Prof — University of Copenhagen
- Study coordinator: Emilie S Nør, Clinical Dietitian, Stud.MSc
- Email: e.noer@rn.dk
- Phone: 004520232289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.