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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

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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

Overall Study

Neoplasms

Nervous System Diseases

Brain Neoplasms

Supratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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

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