Clinical trial · Observational
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum \[Na+\] and the guidelines for the management of this population in Italy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hyponatremia | — | UNRESOLVED | — |
| Syndrome of Inappropriate ADH (SIADH) Secretion | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in serum [Na+]
- timeFrame
- 1 month and 6 months
- description
- Change in serum \[Na+\] from the baseline visit to the end of the first month or sixth month of the observational period or until earlier discontinuation from the study
Secondary outcomes (8)
- measure
- EQ-5D to measure quality of life
- timeFrame
- From baseline up to 6 months
- description
- Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months. EQ-5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
- measure
- EORTC QLQ-C30 to measure quality of life
- timeFrame
- From baseline up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 18 years; 2. Male or female patients with a cytologically or histologically documented cancer diagnosis; 3. Moderate to severe hyponatremia: Na+ level cut off: \[Na+\] \< 130 mmol/L; 4. Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician); 5. No use of diuretic agents within the week prior to evaluation; 6. Willingness to participate in the study; subjects must give their written consent to participate. Exclusion Criteria: 1. Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction; 2. Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia; 3. Life expectancy is lower than 3 months.
References
Publications (0)
Data not yet available