Tracking fluid buildup (edema) in people with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.