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

A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
  • Aosta, Italy
  • Bari, Italy
  • Cagliari, Italy
  • Cosenza, Italy
  • Florence, Italy
  • Genova, Italy
  • Messina, Italy
  • Milan, Italy
  • Napoli, Italy
  • Negrar, Italy
  • Novara, Italy
  • Palermo, Italy
  • Parma, Italy
  • Perugia, Italy
  • Piacenza, Italy
  • Pisa, Italy
  • Roma, Italy
  • Varese, Italy
  • Verona, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Time to chemotherapy (days)		Longitudinal (up to 6 months)
Length of stay (days)		Longitudinal (up to 6 months)
Readmission (number of readmissions)	will be used to evaluate rate of readmissions among this population	Longitudinal (up to 6 months)
Survival status (%)	Will be used to evaluate overall survival (%) among this population after 6 months.	6 months

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Europe Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): December 13, 2017

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Hyponatremia due to SIADH
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases; Water-Electrolyte Imbalance; Hyponatremia; Inappropriate ADH Syndrome
• Other Study ID Numbers: OPEL/2014/067