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NCT Number: NCT02573077

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

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Key information

Conditions

Hyponatremia Brain Diseases Cancer Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Syndrome of Inappropriate ADH (SIADH) Secretion Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ancona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years;
  • Male or female patients with a cytologically or histologically documented cancer diagnosis;
  • Moderate to severe hyponatremia: Na+ level cut off: [Na+] < 130 mmol/L;
  • Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);
  • No use of diuretic agents within the week prior to evaluation;
  • Willingness to participate in the study; subjects must give their written consent to participate.

Exclusion criteria

  • Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;
  • Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;
  • Life expectancy is lower than 3 months.

Treatment and study plan

Primary outcomes

  1. Change in serum [Na+]

    Time frame: 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 outcomes

  1. EQ-5D to measure quality of life

    Time frame: 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.

  2. EORTC QLQ-C30 to measure quality of life

    Time frame: 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.

  3. ECOG PS to assess progress of the disease

    Time frame: 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.

  4. Measure of cognitive impairment: mini-mental state examination (MMSE)

    Time frame: 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.

  5. Time to chemotherapy (days)

    Time frame: Longitudinal (up to 6 months)

  6. Length of stay (days)

    Time frame: Longitudinal (up to 6 months)

  7. Readmission (number of readmissions)

    Time frame: Longitudinal (up to 6 months)

    will be used to evaluate rate of readmissions among this population

  8. Survival status (%)

    Time frame: 6 months

    Will be used to evaluate overall survival (%) among this population after 6 months.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Europe Ltd

Industry

Registry information

Official study title

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

Acronym: ASSERT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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