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

Natriuretic Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Coagulants

Tolvaptan

Hormones

Vasopressins

Arginine Vasopressin

Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days.

Placebo Group: Placebo by mouth once a day for 14 days.

Starting dose 15 mg by mouth once a day for 14 days.

Placebo

Abdulla K. Salahudeen, MD

The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.

The Study Drug:

Tolvaptan is designed to help raise salt levels in your blood by removing extra body water as urine.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group:

* If you are in Group 1, you will take tolvaptan and receive standard of care
* If you are in Group 2, you will take a placebo and receive the standard of care for patients with hyponatremia. A placebo is a tablet that looks like the study drug but has no active ingredients.

You will not know which group you are assigned. However, if needed for your safety, you will be able to find out what you are receiving at any time.

Study Drug Administration:

You will take tolvaptan or the placebo 1 time every day by mouth for 14 days.

If you are receiving the placebo, you will also receive the standard of care for hyponatremia. Examples of the standard of care include limiting your water and fluid intake, or giving you salt tablets and other drugs such as diuretics. Your doctor will describe these in more detail.

You will be given a drug diary to record when you take the study drug/placebo. You will return any unused drug/placebo at the end of 14 days.

You should avoid grapefruit and grapefruit juice while you are taking tolvaptan.

Study Visits:

At every visit, you will be asked if you have had any side effects.

On Days 1, 2, and 3:

* Blood (about 1 teaspoon) will be drawn for routine tests. On Day 1, this sample will be drawn 2 times.
* Your weight and vital signs will be measured.
* The study staff will record how much fluid you are drinking and how much you are urinating.
* You will be asked about any drugs that you may be taking.
* If the doctor thinks it is needed, you will have a physical exam.

On Day 7:

* Your medical history will be reviewed and updated.
* You will be asked about any drugs that you may be taking.
* Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
* Your weight and vital signs will be measured.

On Day 14:

* Your medical history will be reviewed and updated.
* Your weight and vital signs will be measured.
* Blood (about 1 teaspoon) and urine will be collected for routine tests and tests to measure how concentrated your blood and urine are.
* The study staff will record how much fluid you are drinking and how much you are urinating.
* You will be asked about any drugs that you may be taking.
* You will complete the MMSE.

If the doctor thinks it is needed, you will have a physical exam.

Length of Study:

You will take the study drug/placebo for 14 days. You will be taken off study if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study- Day 30 Follow-up Visit:

At 30 days after the last dose of study drug (or placebo), you will have an end-of-study visit in clinic or by telephone. At this visit, the following tests and procedures will be performed.

* Your medical history will be reviewed and updated.
* Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
* You will be asked about any side effects that you may be having and any drugs that you may be taking.
* The study staff will record how much fluid you are drinking and how much you are urinating.
* If the doctor thinks it is needed, you will have a physical exam.

This is an investigational study. Tolvaptan is FDA approved and commercially available to treat hyponatremia (low levels of salt \[sodium\] in the blood due to too much body water). Its use in patients with cancer who have hyponatremia is investigational.

Up to 170 patients will take part in this study. All will be enrolled at MD Anderson.

Tolvaptan in Hyponatremic Cancer Patients

Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer

Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.

Otsuka Pharmaceutical Development & Commercialization, Inc.

M.D. Anderson Cancer Center

Starting dose 15 mg orally once a day for 14 days.

Tolvaptan Group

Placebo Group

Total

United States

Baseline demographics and clinical characteristics of patients in the placebo group and the Tolvaptan Group who completed the 14-Day study.

Carmen Escalante,MD/Chair, General Internal Med

"Evaluable participants" are defined as all participants excluding those who drop out of the study due to non-study related reasons. Participants who are lost to follow-up for unknown or study related reasons will be counted as failures based on the intent to treat principal.

Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14

Length of Stay in Hospital

Brain Neoplasms

Supratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of admission.

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of recruitment.

Serum Sodium

This study was designed to quantify the incidence of hyponatremia in patients of supratentorial/supra-sellar lesions and observe their effect on neurological morbidity and mortality.

Disorders of sodium and water balance are one of the commonly encountered problems while managing patients with neurological diseases. Managing such problems are challenging because the pathophysiology behind these disorders are complex and poorly understood and treatment of the injured brain itself can contribute to, and complicate the diagnosis of sodium disorders. Serum sodium disturbance can manifest as hypernatremia or hyponatremia. Hypernatremia usually occurs in the diabetes insipidus syndrome, whereas hyponatremia develops as a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) or cerebral salt-wasting syndrome (CSWS).

Because of the cerebral effects of hyponatremia, neurosurgical patients are at increased risk of complications including severe cerebral edema, mental status changes, seizures, vasospasm, and death.

Though the problem of hyponatremia has been addressed in patients with different brain pathologies, this has not been studied in patients with non-sellar/suprasellar supratentorial tumors. This study was envisioned to quantify the incidence and magnitude of hyponatremia in this patient population and their subsequent neurological morbidity and mortality.

Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors

To observe relationship between hyponatremia in supratentorial tumor patients and in-hospital mortality.

To observe relationship between hyponatremia in supratentorial tumor patients and duration of hospital stay.

To observe relationship between hyponatremia in supratentorial tumor patients and rate of admission in intensive care unit.

To observe relationship between hyponatremia in supratentorial tumor patients and incidence of neurological deficits.

To observe relationship between hyponatremia in supratentorial tumor patients and incidence of seizures.

National Institute of Mental Health and Neuro Sciences, India

Assistant Professor

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.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

In this retrospective study, the investigators determined the frequency of hyponatremia in small cell lung cancer and the prognosis. 126 (27%) of 466 patients were hyponatremic. Hyponatremia could not be corrected in 50.8% (n=64) of hyponatremic patients. Survival was found to be better in the group of whom hyponatremia was corrected.

Effect of Hyponatremia in Small Cell Lung Cancer

Frequency and Effect on the Prognosis of Hyponatremia During the diagnosıs in Small Cell Lung Cancer

Effect of hyponatremia according to mortality

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Tolvaptan in Hyponatremic Cancer Patients	NCT01199198	Advanced Cancer...	Tolvaptan Placebo	18 Years -	M.D. Anderson Cancer Center
Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors	NCT03570203	Supratentorial ...	Serum Sodium	18 Years -	National Institute of Mental Health and Neuro Sciences, India
Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors	NCT03570203	Supratentorial ...	Serum Sodium	18 Years -	National Institute of Mental Health and Neuro Sciences, India
Tolvaptan in Hyponatremic Cancer Patients	NCT01199198	Advanced Cancer...	Tolvaptan Placebo	18 Years -	M.D. Anderson Cancer Center
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
Effect of Hyponatremia in Small Cell Lung Cancer	NCT04451460	Small Cell Lung...		18 Years -	Ankara City Hospital Bilkent

Spots Global Cancer Trial Database for hyponatremia

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