NCT04939090

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Malignant Solid Neoplasm
• Anorexia
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

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

Timeline

• Start date: 2022-01-03
• Primary completion: 2027-04-01
• Completion: 2027-12-31
• First posted: 2021-06-25
• Last updated: 2026-04-13

Locations

293 sites across 1 country: United States

Regulatory

• FDA-regulated drug study