An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy

Completed

• Conditions: Cancer; Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion

• Registration Number: NCT02573077
• Lead Sponsor: Otsuka Pharmaceutical Europe Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2017-12-13
• Study Completion: 2017-12-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Time to chemotherapy (days)	Longitudinal (up to 6 months)
Survival status (%)	6 months	Will be used to evaluate overall survival (%) among this population after 6 months.
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