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

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 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.

• Authors: R T Chlebowski, L Bulcavage, M Grosvenor, R Tsunokai, J B Block, D Heber, M Scrooc, J S Chlebowski, J Chi, E Oktay
• Journal: Cancer (Cancer) Vol. 59 Issue 3 Pg. 406-10 (Feb 01 1987) ISSN: 0008-543X [Print] United States
• PMID: 3791153 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Hydrazines
• hydrazine

Topics

• Appetite (drug effects)
• Body Weight (drug effects)
• Cachexia (drug therapy, etiology)
• Drug Tolerance
• Energy Intake (drug effects)
• Humans
• Hydrazines (therapeutic use)
• Neoplasms (complications, drug therapy)