Clinical trial NCT05403580: Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in nausea score
timeFrame: Baseline to 24 hours of treatment
Secondary outcomes:
measure: Daily nausea and vomiting scores
timeFrame: Up to 28 days
measure: Daily episodes of vomiting/retching (number and time)
timeFrame: Up to 28 days
measure: Utilization of rescue therapy
timeFrame: Up to 28 days
measure: Incidence of adverse events with olanzapine
timeFrame: Up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic in Rochester
name: Charles L Loprinzi
role: PRINCIPAL_INVESTIGATOR
References: