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

NCT03137121 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: F170104006 (XUAB 16100)000515449
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Cancer

Keywords

nausea; vomiting; olanzapine

Outcome Measures

Primary Outcomes (1)

• Mean Nausea Scores

  Daily nausea scores (the primary objective) on day 1 to 7 of treatment for each patient from the Olanzapine and Placebo group will be measured using the Visual Analogue Scale rankings from 0-10 where 0 is no nausea and 10 is the maximum nausea experienced by a patient. A Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that can't be directly measured. Patients will be asked to record the average nausea score for each day in a diary and a study nurse will call the patient at the same time each day to remind the patient to record the nausea score and to inquire about any toxicities. The difference in the nausea scores for the patients in each group (Olanzapine and Placebo) will be compared.

  Nausea score from the Visual Analogue Scale will be recorded each day daily for 7 days. An average value calculated will be reported for the 7 day period.

Secondary Outcomes (2)

• Number of Emetic Episodes

  Number of emetic episodes for each patient on each day of the seven day treatment.

• Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".

  Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.

Study Arms (2)

Olanzapine

EXPERIMENTAL

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

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Olanzapine DRUG

Olanzapine is used as an anti-emetic.

Also known as: Zyprexa

Olanzapine

Placebo OTHER

The placebo is a non-anti-emetic.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Mayo Clinic: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hospital Sisters Health System (HSHS) St. Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (1)

• 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.

  PMID: 32379269 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rudolph M Navari
• Organization: Univ Alabama Birmingham

rmnavari@gmail.com

574-261-8385

Study Officials

• Rudolph Navari, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will receive the study drug or placebo in a double-blind fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: There will be two groups for the study: Olanzapine Group will receive the study drug and Placebo Group will receive a placebo.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 2, 2017
• Study Start: July 12, 2017
• Primary Completion: July 12, 2019
• Study Completion: September 15, 2020
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)