Tolvaptan in Hyponatremic Cancer Patients
Condition: Advanced Cancers
Intervention: Tolvaptan; Placebo
Intervention description: Starting dose 15 mg by mouth once a day for 14 days.; Placebo by mouth once a day for 14 days.
Intervention MeSH terms: Tolvaptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyponatremia; Serum sodium; Tolvaptan; Placebo

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Euvolemic or hypervolemic (patients with heart or liver failure) with cancer admitted
             to MD Anderson Cancer Center for any reasons with serum sodium between 125 and 130
             mEq/L (both inclusive)

          2. Patients must be greater than or equal to 18 years of age

          3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 at
             baseline.

          4. Women of childbearing potential must use a medically accepted method of contraception
             and to continue use of this method for the duration of the study and for 30 days after
             study participation. Acceptable methods of contraception include abstinence, barrier
             method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral,
             transdermal, implanted, and injected) in conjunction with a barrier method. Men must
             practice abstinence or use a barrier method of birth control, and must agree to
             continue use for the duration of the study and for 30 days after study participation.

          5. Subjects must be able to comply with scheduled visits and follow-ups.

          6. Informed consent must be signed

        Exclusion Criteria:

          1. History of hypersensitivity to tolvaptan

          2. Patients admitted to the critical care unit.

          3. Patients with renal failure(creatinine clearance less than 25 ml/min)

          4. Patients with a life expectancy less than 3 months

          5. Patients with volume depletion, BP < 100/60 or urinary sodium <20 meq/L.

          6. Patients who are not able to swallow or cannot take medication through feeding tubes

          7. Patients with diuretic-induced hyponatremia.

          8. Patients with spurious hyponatremia

          9. Patients with hyponatremia related to psychogenic polydypsia, head trauma, post
             operative conditions, uncontrolled hypothyroidism or cortisol insufficiency or any
             hyponatremia associated with the use of medication that can be safely withdrawn.

         10. The use of alcohol while participating in the study

         11. Currently taking demeclocycline, lithium, benzazepine derivatives, ketoconazole,
             grapefruit, grapefruit juice and receiving strong CYP3A inhibitors such as
             clarithromycin, fluconazole, voriconazole, posaconazole, itraconazole, ritonavir,
             indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin.