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Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
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.
1. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom).
2. Diagnosis of advanced cancer
3. Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day
1. Psychiatric illness which would prevent the patient from giving informed consent
2. Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
3. Patients who cannot swallow oral formulations of the agents
This trial is designed as a Phase III randomized open-label trial to evaluate the effect of olanzapine on cancer associated anorexia. Patients with advanced cancer who suffer from anorexia will be randomized at a 1:1 ratio to receive either olanzapine or megestrol acetate. The randomization will be stratified by gender (male vs. female), cancer type (lung vs. gastrointestinal vs. other), severity of weight loss in the preceding 2 months (< 10 pounds vs. >/= 10 pounds, age (< 50 years vs. >/= 50 years), and anticipated chemotherapy administration over the 4-week trial interval (yes vs. no).