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Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:
A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Clinical Trial Summary

This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.

Clinical Trial Description

The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS). SECONDARY OBJECTIVES: I. To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate. II. To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) instrument. OUTLINE: Patient are randomized to 1 of 2 arms. ARM I: Patients receive olanzapine orally (PO) once daily (QD) for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity. ARM II: Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Anorexia
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Neoplasms
Clinical Trial Details
NCT number NCT04939090
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact Aminah Jatoi, MD
Phone 507-266-9160
Email Jatoi.aminah@mayo.edu
Status Recruiting
Phase Phase 3
Start date January 3, 2022
Completion date December 2024
View Details
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