NCT05403580

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Neoplasm
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
DRUG	Olanzapine	Given PO
DRUG	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-12-29
• Completion: 2024-12-01
• First posted: 2022-06-03
• Last updated: 2024-05-06

Regulatory

• FDA-regulated drug study