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2.1
Treatment
2.11
To compare the appetite-stimulating properties of Megace
versus Marinol versus both for the treatment of cancer-related
(and cancer treatment-related) anorexia and cachexia by
following patient appetite, weight, and the rate of weight
change.
2.12
To evaluate the effect of these drugs on nausea and vomiting
in patients with advanced malignant disease.
2.13
To evaluate the differential effects of these drugs on quality
of life.
2.14
To evaluate possible toxicities related to these drugs.
2.2
Translational
2.21
IL-6: To determine whether IL-6 concentrations decrease
with any of the treatment arms and whether IL-6 concentration
changes correlate with patient appetite changes.
2.22
Neuropeptide g,
Cholecystokinin, Leptin, IL-1b,
and TNFa:
2.221
To determine whether serum concentrations of TNFa,
IL-1b,
neuropeptide g,
cholecystokinin, and leptin predict severity of anorexia
either directly or inversely in patients suffering from
the cancer anorexia/cachexia syndrome. A better understanding
of such serum cytokine/hormone concentrations might allow
for future clinical trials aimed at better treating anorexia.
2.222
To determine whether serum concentrations of TNFa,
IL-1b,
neuropeptide g, cholecystokinin,
and leptin predict response to megestrol acetate, marinol,
or a combination of these two agents with respect to change
in patient-reported appetite and weight gain after one month
of treatment.
2.223
To establish normative values for anorectic-cancer patients
for future reference. An NCCTG clinical trial in patients
with esophageal cancer is scheduled to open in September
of 1999. Investigators involved in this study will be able
to refer to these data from this proposed study to determine
whether hormonal alterations differ between weight-losing
cancer patients suffering from anorexia as opposed to those
suffering from dysphagia.
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