Advanced Cancer Clinical Trial
Official title:
INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has not been approved by the Food and Drug Administration for use to treat weight loss.
Weight loss in cancer patients can be the result of inadequate intake or absorption of
nutrients and/or tumor-induced weight loss due to metabolic changes the tumor is creating in
the body (1). Inadequate intake resulting in a starvation state can simply be the result of
eating less due to depression, nausea/vomiting, feelings of fullness, and taste changes (2).
Though not intentional the weight loss caused by these symptoms can be explained and reversed
by increasing intake of nutrients. Unintentional weight loss induced by the tumor can be
caused by multiple physiological factors that increase the catabolism of muscle and fat and
increased nutrient intake alone may not reverse the weight loss. Unintentional weight loss
can predict a poor prognosis in cancer patients which is most likely due to decreased doses
of treatment (3-5).
Usual care for weight loss in cancer patients varies among practitioners and can include
nutrition counseling by a registered dietitian or by the practitioner themselves. Treatment
can vary from counseling patients to increase intake of nutrient dense foods to prescribing
medications in order to improve appetite or mood, to decrease feelings of fullness, or to
control nausea/vomiting, etc. (6). However, these interventions do not always work. For
varied reasons not all patients are able to improve their oral intake of food items and in
patients with tumor induced weight loss increased oral intake does not improve the metabolic
changes.
Anti-depressant medications have weight related side effects (7-9). Mirtazapine has been
shown to have side effects of increased appetite and increased weight in cancer subjects
studied for use with depression and nausea. (10-13). These results appeared to range from
changes in appetite to changes seen in metabolic processes such as changes in the cytokine
system to reduce inflammation seen in cachectic patients. Therefore, using mirtazapine in
cancer patients even without depression may help to stop unwanted weight loss and increase
survival by allowing patient to complete prescribed treatment.
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