About Herbs

Bottom Line: Hydrazine sulfate is not an approved cancer treatment. In fact, it has been shown to increase the incidence of some cancers in animals.

Hydrazine sulfate is a man-made chemical that is used in industrial manufacturing of agricultural chemicals and rocket fuel. Supporters of this therapy make the false claim that hydrazine sulfate limits the ability of tumor cells to make glucose, an important source of their energy, from body stores. In theory, this would also prevent the accelerated breakdown of protein in the body that causes cachexia (wasting) in patients with advanced cancer, however, this effect has never been shown in humans. Hydrazine sulfate was able to inhibit the growth of some tumors in laboratory animals when used alone or with chemotherapy drugs, but this effect has also not been shown in humans. Furthermore, hydrazine sulfate has been shown to increase the incidence of breast, lung, and liver cancers in laboratory animals.

Cancer treatment:
Hydrazine sulfate was used in combination with standard chemotherapy in a 1994 study of 266 patients with non-small cell lung cancer (NSCLC). Patients were given either 60 mg of hydrazine sulfate or a placebo pill three times daily. The average survival for both groups of patients was about eight months, and there was no difference in tumor shrinkage or weight gain between patients taking hydrazine sulfate and those taking placebo. However, side effects were more common and quality of life was worse in patients taking hydrazine sulfate. This is strong evidence that hydrazine sulfate is not an effective cancer treatment for NSCLC.

Another 1994 study examined 237 patients with newly diagnosed non-small cell lung cancer (NSCLC) to test the effectiveness of hydrazine sulfate in combination with cisplatin and etoposide (chemotherapy drugs). Patients were given either 60 mg of hydrazine sulfate or a placebo pill three times daily. There was no significant difference in survival, tumor shrinkage, or quality of life between patients taking hydrazine sulfate and placebo, although patients taking hydrazine sulfate experienced more side effects. This further supports the finding that hydrazine sulfate is not an effective cancer treatment for NSCLC.

The effectiveness of hydrazine sulfate when used alone was studied in 127 patients with colorectal cancer. Patients were given either a placebo pill or 60 mg of hydrazine sulfate three times a day indefinitely. When all of the variables that might have effected patients' outcomes were taken into account, patients taking hydrazine sulfate had shorter survival times and no improvement in weight gain. Hydrazine sulfate appears to be worse than no treatment at all for advanced colorectal cancer.

A 1987 study observed the effects of hydrazine sulfate on body weight, appetite, and caloric intake in cancer patients. Seventy-one patients received 60 mg of hydrazine sulfate three times a day and 30 received a placebo pill. Use of hydrazine sulfate was linked to a short-term improvement in appetite, weight maintenance, and caloric intake, but the long-term effects of the therapy and the survival of the patients are not discussed in this study. Patients taking hydrazine sulfate reported side effects that included light-headedness, nausea and vomiting.

Sehydrin, hydrazine, hydrazine monosulfate, HS

A synthetic chemical (H₄N₂-H₂SO₄) primarily used in industrial manufacturing (e.g. agricultural chemicals, rocket fuel, etc). Patients use hydrazine sulfate to treat cancer, maintain or gain weight, and ameliorate cancer-related cachexia. It is thought to interfere with gluconeogenesis via the inhibition of phosphoenolpyruvate carboxykinase ⁽¹⁾. It has moderate monoamine oxidase inhibitor (MAO-I) activity ⁽³⁾. Several large randomized clinical trials failed to show overall significant benefit from hydrazine supplementation ^{(7) (8) (9)}. Animal studies suggest that hydrazine is carcinogenic, although it is not established in humans. Potential adverse effects include nausea, pruritus, dizziness, peripheral neuropathies, hypoglycemia and insomnia ⁽⁴⁾. Case reports detailing fatal hepatorenal failure ⁽⁵⁾ and encephalopathy ⁽⁶⁾ exist in the literature. Potential drug interactions include increased hydrazine toxicity when combined with benzodiazepines, barbiturates, and alcohol ^{(1) (4)}. Theoretically, foods high in tyramine content, meperidine, sympathomimetics, and dextromethorphan should be avoided due to MAO-I activity ⁽³⁾. Hydrazine sulfate has not been proven to alleviate cancer-related cachexia ⁽¹⁰⁾ or to improve cancer survival.

Hydrazine sulfate is thought to inhibit phosphoenolpyruvate carboxykinase, an enzyme involved with the Cori cycle for gluconeogenesis from anaerobically metabolized lactic acid. Hydrazine therapy is used to antagonize the inappropriate activation of gluconeogenesis pathways, reduce excessive gluconeogenesis, and improve glucose tolerance particularly in patients with cancer and cancer-related cachexia ⁽¹⁾. Hydrazine also has been shown to be a weak monoamine oxidase inhibitor ⁽³⁾. Inhibition and stabilization of glioblastoma cell growth was seen in vitro and in animal models ⁽⁴⁾, but significance in humans is unknown. Hydrazine sulfate appears to have no effect on prostate cancer cell lines in vitro ⁽²⁾.

Hydrazine is classified as a carcinogen.

Patients with diabetes should use this product with caution due to potential hypoglycemia.

Common: Nausea, pruritus, dizziness, sedation, peripheral neuropathies, hypoglycemia, insomnia ⁽⁴⁾
Case reports: Hepatorenal failure ⁽⁵⁾, encephalopathy ⁽⁶⁾
Food interactions: Foods containing high amounts of tyramine (red wine, aged cheeses, etc) should be avoided.

Kosty MP, et al. Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the cancer and leukemia group B. J Clin Oncol 1994;12:1113-20.
A prospective evaluation of 266 patients with primary non-small cell lung cancer (NSCLC) randomized to receive placebo or 60 mg hydrazine sulfate PO three times daily in combination with standard chemotherapy. Primary outcomes included toxicity and response. Survival was calculated and estimated using Kaplan-Meier. There were no significant differences between treatment groups at baseline. No difference in response rates or survival was noted. Sensory and motor neuropathies were seen more frequently in patients receiving hydrazine sulfate (p < 0.05). No improvements in albumin or weight were noted between treatment groups. The use of hydrazine sulfate with cisplatin and vinblastine for NSCLC appeared to have no significant advantage over placebo.

Loprinzi CL, et al. Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small cell lung cancer. J Clin Oncol 1994;12:1126-9.
A prospective evaluation of 237 patients randomized to receive either placebo or 60 mg hydrazine sulfate PO three times daily in combination with cisplatin and etoposide. Primary outcomes were survival and quality of life; response and weight were secondary outcomes. There was no significant difference between treatment groups with the addition of hydrazine sulfate. Additional CNS toxicity was noted in the hydrazine sulfate group, including dizziness and headache. No improvement in weight or albumin was noted between treatment groups, but it should be noted that cancer-related cachexia may not have been an issue in newly diagnosed NSCLC patients.

Loprinzi CL, et al. Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. J Clin Oncol 1994;12:1121-5.
A prospective evaluation of 127 patients not receiving chemotherapy, randomized to either placebo or 60 mg hydrazine sulfate PO three times a day indefinitely. Cox proportional hazards model was used to assess the effects of stratification by ECOG performance status, sex, weight, number of previous chemotherapy regimens, and measurable disease. Inferior survival was shown repeatedly for hydrazine as compared to placebo. Hydrazine appeared to offer no improvement in weight gain or improvement as compared to placebo. Toxicity appeared to be similar between treatment arms. Hydrazine sulfate appears to be worse than placebo for the management of advanced colorectal cancer.

Chlebowski RT, et al. Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. Cancer 1987;59:406-10.
A randomized clinical observation of placebo versus 60 mg PO three times daily hydrazine sulfate on body weight, albumin, caloric intake, and toxicity. Seventy-one patients received hydrazine and 30 placebo. Only 58 patients completed repeat evaluations after 30 days; results indicate a short-term benefit associated with hydrazine sulfate with respect to weight maintained, improvement in appetite, and caloric intake. The author does not disclose the reason for patient discontinuation in either placebo or hydrazine group. Adverse events associated with hydrazine included light-headedness, nausea and vomiting, and "toxic effects" not otherwise specified. The author concludes that hydrazine leads to short term improvement in appetite and caloric intake. However, the study does not address long-term effects, nor does it reveal important information needed to interpret study results.