Symptoms and General Pathology

All Conditions

Neoplasms

Nutritional and Metabolic Diseases

Nervous System Diseases

Gland and Hormone Related Diseases

Syndrome

Neoplasm Metastasis

Hyponatremia

Inappropriate ADH Syndrome

Water-Electrolyte Imbalance

Metabolic Diseases

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Medical Department

In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed. Since it is hypothesised that the adherence to the SEOM algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the SEOM algorithm and its impact on patient outcomes

An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

An Observational, Retrospective Study to Describe the Extent of Adherence to the Spanish Society of Medical Oncology Algorithm for the Treatment of Hyponatraemia Secondary to SIADH in Oncology Patients in Spain (ALGA)

Adherence to the algorithm will be evaluated using a pre-defined decision tree that will be provided in the electronic case report form (eCRF) and will be completed by the investigator

Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels \[censored patients\]).

Otsuka Pharmaceutical Europe Ltd

Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level \<135 mmol/L)

Oncology Patients With Hyponatraemia

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

Weight

Height

Body Mass Index

Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients).

Number of Patients Managed According to the SEOM Algorithm (as a Result Adherence to the Algorithm Will be the % of These Patients Among the Total Number of Patients)

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm.

Participants Treated According to SEOM Algorithm

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.

Participant NOT Treated According to SEOM Algorithm

The overall number of patients analysed represents the number of participants for which the data (time in days) was available. As a retrospective chart review, there were some missing data in this outcome measure (date of improvement in this case)

Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred.

Subjects With Chemotherapy Treated as Per SEOM Algorithm

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH NOT according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred

Subjects With Chemotherapy NOT Treated as Per SEOM Algorithm

In this analysis, only the 22 patients who were candidate for chemotherapy during the study period were included, this explains the difference with the total number of participants.

Time to Initiation or Re-initiation of Chemotherapy (Since the Start of the Hyponatraemia Episode) in Patients Candidate for Chemotherapy Who Were and Were Not Treated in Adherence With the SEOM Algorithm.

Length of Hospitalisation (Measured From the Start of the Hyponatraemia Episode to Discharge) for Patients Who Were and Were Not Treated in Adherence With the Algorithm

The overall number of patients analysed represents the number of participants for which the data (time in hours) was available. As a retrospective chart review, there were some missing data in this outcome measure (time of improvement in this case)

Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)

Overall Study

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.

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

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

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

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.

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.

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.

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.

will be used to evaluate rate of readmissions among this population

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain	NCT02548845	Hyponatremia Syndrome of Ina...		18 Years -	Otsuka Pharmaceutical Europe Ltd
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy	NCT02573077	Hyponatremia Syndrome of Ina... Cancer		18 Years -	Otsuka Pharmaceutical Europe Ltd

Spots Global Cancer Trial Database for syndrome of inappropriate adh (siadh) secretion