Cancer, Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Conditions
Keywords
Hyponatremia due to SIADH, Cancer
Brief summary
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.
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Europe Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum [Na+] | 1 month and 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 to measure quality of life | From baseline up to 6 months | Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months. EORTC QLC-C30: European Organisation for Research and Treatment of Cancer (EORTC) Study Group on Quality of Life has developed the EORTC QLQ-C30 questionnaire consisting in a modular system for assessing the quality of life of cancer patients in clinical research. |
| ECOG PS to assess progress of the disease | From baseline up to 6 months | Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months. The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate (oncology) treatment and prognosis. |
| Measure of cognitive impairment: mini-mental state examination (MMSE) | From baseline up to 6 months | Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months. The mini-mental state examination (MMSE) or Folstein test is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. |
| EQ-5D to measure quality of life | From baseline up to 6 months | 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. |
| Length of stay (days) | Longitudinal (up to 6 months) | — |
| Readmission (number of readmissions) | Longitudinal (up to 6 months) | will be used to evaluate rate of readmissions among this population |
| Survival status (%) | 6 months | Will be used to evaluate overall survival (%) among this population after 6 months. |
| Time to chemotherapy (days) | Longitudinal (up to 6 months) | — |
Countries
Italy
Outcome results
None listed