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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Otsuka Pharmaceutical Europe Ltd

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.

  • 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.

  • 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.

  • 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.

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


Original Secondary Outcome: Same as current

Information By: Otsuka Pharmaceutical Europe Ltd

Dates:
Date Received: October 6, 2015
Date Started: October 2015
Date Completion: September 2017
Last Updated: October 20, 2016
Last Verified: October 2016