Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

NCT ID: NCT03137121

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-12
• Study Completion Date: 2020-09-15

Brief Summary

The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

Detailed Description

Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in >60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.

Conditions

Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Olanzapine

Patients will receive 5 mg olanzapine orally for 1 to 7 days daily.

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Olanzapine is used as an anti-emetic.

Placebo

Patients will receive a placebo orally for 1 to 7 days daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo is a non-anti-emetic.

Interventions

Olanzapine

Olanzapine is used as an anti-emetic.

Intervention Type: DRUG

Placebo

The placebo is a non-anti-emetic.

Intervention Type: OTHER

Other Intervention Names

Zyprexa

Eligibility Criteria

Inclusion Criteria

• Be at least 18 years of age
• Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
• Have not received chemotherapy or radiation for >14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
• Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
• Have serum creatinine < 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 times upper limits of normal ≤120 days prior to registration
• Absolute neutrophil count (ANC) >1500 mm3 <120 days prior to registration
• Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test <7 days prior to registration.

Exclusion Criteria

• Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
• Not have concurrent use of ethyol
• Not have severe cognitive compromise
• History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
• Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
• Chronic alcoholism (as determined by the investigator)
• Known hypersensitivity to olanzapine
• Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
• History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
• Planned chemotherapy or radiation during the 7 days following study initiation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Rudolph Navari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rudolph Navari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hospital Sisters Health System (HSHS) St. Vincent Hospital

Green Bay, Wisconsin, United States

Countries

United States

References

Navari RM, Pywell CM, Le-Rademacher JG, White P, Dodge AB, Albany C, Loprinzi CL. Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial. JAMA Oncol. 2020 Jun 1;6(6):895-899. doi: 10.1001/jamaoncol.2020.1052.

Reference Type: DERIVED

PMID: 32379269 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

000515449

Identifier Type: OTHER

Identifier Source: secondary_id

F170104006 (XUAB 16100)

Identifier Type: -

Identifier Source: org_study_id