Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience

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Abstract
Hydrazine sulfate was evaluated using 24‐hour dietary recalls and body weight determinations before and after 30 days of either placebo or hydrazine (60 mg, 3 times/d) oral administration in 101 heavily pretreated cancer patients with weight loss. After 1 month, 83% of hydrazine and only 53% of placebo patients completing repeat evaluation maintained or increased their weight (P < 0.05). In addition, appetite improvement was more frequent in the hydrazine group (63% versus 25%, P < 0.05). Although caloric intake was only slightly greater in hydrazine‐treated patients, an increased caloric intake was more commonly associated with weight gain in patients receiving hydrazine compared with those receiving placebo (81% versus 53%, respectively). Hydrazine toxicity was mild, with 71% of patients reporting no toxic effects. Hydrazine sulfate circulatory levels were obtained from a subset of 14 patients who completed 30 days of treatment, with a single sample obtained in the morning at least 9 hours after the last dose. Mean maintenance hydrazine sulfate levels, determined using a spectroflurometric assay, ranged from 0 to 89 ng/ml (mean 45 ± 16 ng/ml). These data, which demonstrate an association between 1 month of hydrazine sulfate administration and body weight maintenance in patients with cancer, suggest future clinical trials of hydrazine sulfate are indicated to definitively assess its long‐term impact on important clinical outcome parameters in defined cancer populations.