In a double-blind placebo-controlled trial, 57 adult subjects with disseminated malignancies were given orally low doses of recombinant human interferon-alpha (rHuIFN-alpha) at 0.05 IU, 0.5 IU, or 5.0 IU/kg body weight. The objective was to determine the efficacy of orally administered rHuIFN-alpha on appetite stimulation and/or weight loss prevention in anorectic cancer patients. Almost two-thirds (64%) of the subjects given 5.0 IU/kg reported an increase in appetite or body weight after 5 weeks in contrast to only 29% of the placebo-treated subjects. However, at the end of the 91-day trial, no significant differences in appetite enhancement or weight gain were noted between these two groups. Additionally, the 5.0 IU/kg treated group experienced half as many deaths as the control group by the conclusion of this 91-day trial.