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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573077
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hyponatremia Syndrome of Inappropriate ADH (SIADH) Secretion Cancer

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573077


Locations
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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
Sponsors and Collaborators
Otsuka Pharmaceutical Europe Ltd
Investigators
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Study Director: Medical Department Otsuka Europe
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Responsible Party: Otsuka Pharmaceutical Europe Ltd
ClinicalTrials.gov Identifier: NCT02573077    
Other Study ID Numbers: OPEL/2014/067
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by Otsuka Pharmaceutical Europe Ltd:
Hyponatremia due to SIADH
Cancer
Additional relevant MeSH terms:
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Inappropriate ADH Syndrome
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases