Clinical trial NCT02573077: An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Official title: A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Syndrome of Inappropriate ADH (SIADH) Secretion
Cancer
Keywords: Hyponatremia due to SIADH
Cancer
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This non-interventional study will include cancer patients who need a treatment for hyponatremia secondary to SIADH in one of the hospitals participating in the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum [Na+]
timeFrame: 1 month and 6 months
Secondary outcomes:
measure: EQ-5D to measure quality of life
timeFrame: From baseline up to 6 months
measure: EORTC QLQ-C30 to measure quality of life
timeFrame: From baseline up to 6 months
measure: ECOG PS to assess progress of the disease
timeFrame: From baseline up to 6 months
measure: Measure of cognitive impairment: mini-mental state examination (MMSE)
timeFrame: From baseline up to 6 months
measure: Time to chemotherapy (days)
timeFrame: Longitudinal (up to 6 months)
measure: Length of stay (days)
timeFrame: Longitudinal (up to 6 months)
measure: Readmission (number of readmissions)
timeFrame: Longitudinal (up to 6 months)
measure: Survival status (%)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ancona
country: Italy
city: Aosta
country: Italy
city: Bari
country: Italy
city: Cagliari
country: Italy
city: Cosenza
country: Italy
city: Florence
country: Italy
city: Genova
country: Italy
city: Messina
country: Italy
city: Milan
country: Italy
city: Napoli
country: Italy
city: Negrar
country: Italy
city: Novara
country: Italy
city: Palermo
country: Italy
city: Parma
country: Italy
city: Perugia
country: Italy
city: Piacenza
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Varese
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References: