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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
360
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
RECRUITINGCTCA at Western Regional Medical Center
Goodyear, Arizona, United States
RECRUITINGArizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
RECRUITINGArizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States
Change in appetite
Will be compared between the two study groups (olanzapine versus megestrol acetate) using a 0-10 numerical rating scale. Will be summarized by mean (standard deviation \[SD\]) and median (range) by treatment arm. The difference in appetite change from baseline to 4 weeks of treatment between arms will be estimated along with a 95% confidence interval and will be compared using a t-test or Wilcoxon rank-sum test as appropriate.
Time frame: Baseline up to 4 weeks
Proportion of patients who report a 5% or greater weight gain
The proportion of patients with a 5% or greater weight gain from baseline will be calculated for each arm. The difference in proportion of patients with 5% or greater weight gain between the arms will be estimated along with a 95% confidence interval using a normal approximation of the binomial distribution and will be compared using a Chi-squared test.
Time frame: Baseline up to 4 weeks
Change in well-being status and cachexia/anorexia symptoms
Responses to the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) questionnaire will be scored according to the established algorithm. The total score of the FAACT-A/CS will be summarized weekly and the change from baseline to 4 weeks will be compared between the treatment arms using the same methods described for the primary endpoint.
Time frame: Baseline up to 4 weeks
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Arizona Center for Cancer Care - Osborn
Scottsdale, Arizona, United States
RECRUITINGArizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States
RECRUITINGArizona Center for Cancer Care-Surprise
Surprise, Arizona, United States
RECRUITINGNEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
RECRUITINGEpic Care-Dublin
Dublin, California, United States
ACTIVE_NOT_RECRUITINGEpic Care Partners in Cancer Care
Emeryville, California, United States
ACTIVE_NOT_RECRUITING...and 283 more locations