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

Journal Article (Clinical Trial;Journal Article)

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 less than 0.05). In addition, appetite improvement was more frequent in the hydrazine group (63% versus 25%, P less than 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 spectrofluorometric 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.

Full Text

Duke Authors

Cited Authors

  • Chlebowski, RT; Bulcavage, L; Grosvenor, M; Tsunokai, R; Block, JB; Heber, D; Scrooc, M; Chlebowski, JS; Chi, J; Oktay, E

Published Date

  • February 1, 1987

Published In

Volume / Issue

  • 59 / 3

Start / End Page

  • 406 - 410

PubMed ID

  • 3791153

International Standard Serial Number (ISSN)

  • 0008-543X

Digital Object Identifier (DOI)

  • 10.1002/1097-0142(19870201)59:3<406::aid-cncr2820590309>3.0.co;2-w


  • eng

Conference Location

  • United States