All patients received nutrition counseling to increase their intake of calories and nutrients, with no request to limit alcohol intake and no prohibition of barbiturates. Data from the study suggested that some patients who took hydrazine sulfate those who were in good condition before the study began had about a 17-week increase in survival. Preliminary findings from the study were presented in early 1987, and the study was published in January 1990. Based on the findings of this pilot study, NCI sponsored three large-scale clinical trials of the effects of hydrazine sulfate in patients with two types of advanced cancer nonsmall cell lung cancer and colon cancer. Other drugs thought to stimulate appetite were not permitted.
Records show that at least one patient received barbituates.
The study results, which did not show any benefit from hydrazine sulfate, were published in June 1994. Because this chemotherapy regimen induces severe nausea and vomiting, patients were given antiemetic medications. The antiemetics included benzodiazepines, phenothiazines, and serotonin antagonists. Use of barbiturates and consumption of alcohol was prohibited. The researchers did not find any differences in survival, tumor regression, toxicities, or quality of life between the patients who received hydrazine sulfate and those who received the placebo.