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

Cancer Clinical Trial

— ASSERT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573077
• Other study ID #: OPEL/2014/067
• Status: Completed
• First received: October 6, 2015
• Last updated: April 3, 2018
• Start date: October 2015
• Est. completion date: December 13, 2017

Study information

• Verified date: April 2018
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Hyponatremia
• Inappropriate ADH Syndrome
• Syndrome of Inappropriate ADH (SIADH) Secretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum [Na+]	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	1 month and 6 months
Secondary	EQ-5D to measure quality of life	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.	From baseline up to 6 months
Secondary	EORTC QLQ-C30 to measure quality of life	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.	From baseline up to 6 months
Secondary	ECOG PS to assess progress of the disease	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.	From baseline up to 6 months
Secondary	Measure of cognitive impairment: mini-mental state examination (MMSE)	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.	From baseline up to 6 months
Secondary	Time to chemotherapy (days)		Longitudinal (up to 6 months)
Secondary	Length of stay (days)		Longitudinal (up to 6 months)
Secondary	Readmission (number of readmissions)	will be used to evaluate rate of readmissions among this population	Longitudinal (up to 6 months)
Secondary	Survival status (%)	Will be used to evaluate overall survival (%) among this population after 6 months.	6 months