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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05403580
• Other study ID #: MC211002
• Secondary ID: NCI-2022-02478MC
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 3, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.

Description:

PRIMARY OBJECTIVE:

I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.

II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive olanzapine orally (PO) every night on days 1-28.

ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years

• Histologically or cytologically-confirmed cancer in an advanced incurable stage

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

• Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)

• Serum creatinine < 2.0 mg/dl =< 120 days prior to registration

• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) values < 3 times upper limits of normal =< 120 days prior to registration

• Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only

• Able to provide written informed consent

• Able to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

• Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:

• Pregnant persons

• Nursing persons

• Received chemotherapy or radiation within the prior 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)

• Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)

• Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation

• Uncontrolled intercurrent illness including, but not limited to:

• Ongoing or active infection (including human immunodeficiency virus [HIV])

• Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

• Psychiatric illness/social situations that would limit compliance with study requirements

• Inability to swallow oral formulations of the agent(s)

• Tube feeding or nasogastric tube

Related Conditions & MeSH terms

• Advanced Malignant Solid Neoplasm
• Hematopoietic and Lymphoid Cell Neoplasm
• Neoplasms
• Vomiting

Intervention

Drug:
• Olanzapine
Given PO
• Placebo Administration
Given PO

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nausea score	Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.	Baseline to 24 hours of treatment
Secondary	Daily nausea and vomiting scores	Chronic nausea this is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).	Up to 28 days
Secondary	Daily episodes of vomiting/retching (number and time)	Chronic nausea that is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).	Up to 28 days
Secondary	Utilization of rescue therapy	Baseline evaluation that includes assessment of symptom intensity for appetite, nausea, fatigue, sedation, and pain, all measured and recorded on a numeric rating score. (0 indicated the worst possible; 10, best possible).	Up to 28 days
Secondary	Incidence of adverse events with olanzapine	Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.	Up to 28 days