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

Advanced Cancer Clinical Trial

Official title:

Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137121
• Other study ID #: F170104006 (XUAB 16100)
• Secondary ID: 000515449
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 12, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: July 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2020
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Nausea
• Neoplasms
• Vomiting

Intervention

Drug:
• Olanzapine
Olanzapine is used as an anti-emetic.

Other:
• Placebo
The placebo is a non-anti-emetic.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Hospital Sisters Health System (HSHS) St. Vincent Hospital	Green Bay	Wisconsin
United States	Indiana University	Indianapolis	Indiana
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Emetic Episodes	The number of emetic episodes (a secondary outcome) by each patient in each group, Olanzapine & Placebo, on each day of treatment will be recorded by each patient on each day of treatment in a diary. A study nurse will contact each patient at the same time of each day of the study to ask the patient to record the number of emetic episodes and report any toxicities.The number of emetic episodes for the patients in each Group for each day of the treatment will be compared.	Number of emetic episodes for each patient on each day of the seven day treatment.
Secondary	Number of Treatment-related Adverse Events as Assessed by CTCAE v4.0".	Adverse events will be measured by patient-reported outcomes questionnaires and the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A study nurse will contact each patient each day of the seven days of treatment to inquire about any toxicities, specifically sedation and appetite. Sedation and appetite will be reported by the patient in each Group on a Visual Analogue Scale of 0 to 10 with 0 being no sedation or no appetite to 10 indicating maximum sedation or maximum appetite.	Daily assessment for 7 days for each patient in Olanzapine & Placebo Groups.