Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Olanzapine 5 MG; Placebo
Intervention description: It will be a de-identified pill created by investigational drug services at University of North Carolina; It will be a de-identified pill created by investigational drug services at University of North Carolina
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chemotherapy-induced Nausea and Vomiting; Chemotherapy; Nausea and Vomiting; Olanzapine

Summary:

      The purpose of this research study is to see if olanzapine helps to prevent nausea and/or
      vomiting (throwing up) when it is added to other medicines in subjects having stem cell
      transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo)
      before getting any chemotherapy that is known to cause nausea and vomiting. During the study,
      the study coordinators will ask the subjects to complete surveys to understand if the patient
      is having nausea and vomiting, and if so, how bad it is making the patient feel.

      This trial will split subjects into two groups: one group will be given an inactive pill
      (placebo), and the other group will be given the active pill (olanzapine). Study coordinators
      will collect surveys every morning before chemotherapy and 5 days after the last dose of
      chemotherapy. These surveys may be given by members of the study team or possibly on a mobile
      device.

      Subjects may benefit from being in this research study because olanzapine may reduce the
      frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common
      risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low
      blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood
      pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function
      test changes however these risks are less common in subjects with cancer. In addition, there
      may be a change detected in heart rhythm however subjects will be screened for this ahead of
      time.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent was obtained to participate in the study and HIPAA
             authorization for the release of personal health information.

          2. Recipients receiving autologous or allogeneic HCT for any disease

          3. Any conditioning chemotherapy regimen considered a standard bone marrow
             transplantation conditioning regimen

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          5. The subject is willing and able to comply with study procedures based on the judgment
             of the investigator or protocol designee.

        Exclusion Criteria:

          1. Patients must not have started conditioning chemotherapy prior to consent. Note: test
             dose Busulfan is not part of conditioning chemotherapy

          2. Known allergy to olanzapine

          3. Baseline corrected QT interval ( QTc )>500 msec as calculated by the Fridericia
             formula

          4. Patients receiving post-transplant cyclophosphamide as planned graft-versus-host
             disease (GVHD) prophylaxis

          5. Pregnant or breastfeeding (NOTE: patients pregnant or breast-feeding are not eligible
             to proceed to transplant).

          6. Has a known additional malignancy that is active and/or progressive requiring
             treatment; exceptions include basal cell or squamous cell skin cancer, in situ
             cervical or bladder cancer, or other cancer for which the subject has been
             disease-free for at least five years.

          7. Treatment with any investigational drug within 7 days prior to registration.

          8. Subject is receiving prohibited medications (ciprofloxacin or fluvoxamine) that cannot
             be discontinued/replaced by an alternative therapy.