Olanzapine versus Megestrol Acetate for the Treatment of Loss of Appetite among Advanced Cancer Patients

Active:	Yes
Cancer Type:	Hematopoietic Malignancies	NCT ID:	NCT04939090
Trial Phases:	Phase III	Protocol IDs:	A222004 (primary) A222004 A222004 NCI-2021-03303
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT04939090

Summary

This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Olanzapine is studied in the treatment of nausea and vomiting caused by some cancer treatments and may stimulate and increase appetite. Megestrol acetate works by stimulating patients appetites in order to treat or prevent weight loss. This study is looking at the effect of olanzapine on appetite and weight loss in patients with advanced cancer and determining whether it is better or worse than megestrol acetate.

Objectives

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.

EXPLORATORY OBJECTIVES:
I. To describe the trajectory of appetite scores from baseline to end of treatment by arm using the NRS.
II. To describe the trajectory of weight from baseline to end of treatment by arm.
III. To explore the difference in trajectory of nausea, vomiting, fatigue, pain, quality of sleep, anxiety/stress, and sense of taste and smell from baseline to end of treatment between olanzapine and to megestrol acetate.
IV. To explore whether olanzapine will decrease the use of other antiemetic drugs compared to megestrol acetate.
V. To describe the adverse event profiles of olanzapine versus megestrol acetate.
VI. To report weekly appetite change by treatment and race/ethnicity.

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 disease progression or unacceptable toxicity.

ARM II: Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at screening and may undergo additional blood sample collection on study.

At the end of the study intervention, patients are followed within 30 days.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.