A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia
A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Jonesboro, Arkansas 72401, United States
Washington D.C., District of Columbia 20002, United States
Brighton, Michigan 48114, United States
Chelsea, Michigan 48118, United States
East China Township, Michigan 48054, United States
Ypsilanti, Michigan 48197, United States
Columbus, Mississippi 39705, United States
New Albany, Mississippi 38652, United States
Washington, North Carolina 27889, United States
Collierville, Tennessee 38017, United States
Berlin Corners, Vermont 05602, United States
Sturgeon Bay, Wisconsin 54235-1495, United States