- How It Works
- Purported Uses
- Research Evidence
- Patient Warnings
- Side Effects
- Special Point
- Dosage (Inside MSKCC Only)
Common Name
Sehydrin, hydrazine, hydrazine monosulfate, HS
Clinical Summary
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).
Animal studies suggest that hydrazine is carcinogenic, although it is not established in humans. Several large randomized clinical trials failed to show significant benefit from hydrazine supplementation (7) (8) (9), alleviate cancer-related cachexia (10) or to improve cancer survival.
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).
Purported Uses
- Cancer treatment
- Cancer-related cachexia
- Weight gain
- Weight maintenance
Constituents
- Chemical formula: H4N2-H2SO4
- Molecular weight: 130
Mechanism of Action
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).
Warnings
Hydrazine is classified as a carcinogen.
Contraindications
Patients with diabetes should use this product with caution due to potential hypoglycemia.
Adverse Reactions
- Common: Nausea, pruritus, dizziness, sedation, peripheral neuropathies, hypoglycemia, insomnia. (4)
- Case reports
Hepatorenal failure (5) and encephalopathy (6) have been reported with use of hydrazine sulfate.
Multiple basal cell carcinoma has been associated with extensive exposure to hydrazine sulfate in a 68-year-old man (11).
Herb-Drug Interactions
Literature Summary and Critique
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.
References
- Kaegi E. Unconventional therapies for cancer: 4. Hydrazine sulfate. The Task Force on Alternative Therapies of the Canadian Breast Cancer Research Initiative. CMAJ 1998;158:1327-30.
- Kamradt JM, Pienta KJ. The effect of hydrazine sulfate on prostate cancer growth. Oncol Rep 1998;5:919-21.
- Chlebowski RT, et al. Hydrazine sulfate: clinical pharmacokinetics and influence on in vitro growth of human glioblastoma cell lines. Proc Am Assoc Cancer Res 1985;26:1002.
- Hydrazine sulfate (pdq). Available at http://www.cancer.gov/cancertopics/pdq/cam/hydrazinesulfate/healthprofessional. Accessed May 25, 2011.
- Hainer MI, et al. Fatal hepatorenal failure associated with hydrazine sulfate. Ann Intern Med 2000;133:877-80.
- Nagappan R, Riddel T. Pyridoxine therapy in a patient with severe hydrazine sulfate toxicity. Crit Care Med 2000;28:2116-8.
- 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.
- 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.
- Loprinzi CL, et al. Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. J Clin Oncol 1994;12:1121-5.
- Chlebowski RT, et al. Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. Cancer 1987;59:406-10.
- Aigner BA, Darsow U, Grosber M, Ring J, Plötz SG. Multiple basal cell carcinomas after long-term exposure to hydrazine: case report and review of the literature. Dermatology. 2010;221(4):300-2.
How It Works
Bottom Line: Hydrazine sulfate is not an approved cancer treatment. It has been shown to increase the incidence of some cancers.
Hydrazine sulfate is a chemical 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 and basal cell carcinoma.
Purported Uses
- To prevent wasting (cachexia), maintain weight, and increase appetite in patients with advanced cancer
There is no scientific evidence to support this use. - To treat cancer
Clinical trials do not support this use, and one actually showed that hydrazine sulfate was worse than no treatment at all.
Research Evidence
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.
Patient Warnings
- Hydrazine sulfate is classified as a potential carcinogen by the U.S. Department of Health and Human Services.
- This product is regulated by the FDA as a dietary supplement. Unlike approved drugs, supplements are not required to be manufactured under specific standardized conditions. This product may not contain the labeled amount or may be contaminated. In addition, it may not have been tested for safety or effectiveness.
Side Effects
- Nausea
- Itching
- Dizziness
- Sedation
- Peripheral neuropathies
- Low blood sugar
- Insomnia
- There have been isolated cases of liver and kidney failure and encephalopathy.
- Multiple basal cell carcinomas were reported in a 68-year-old man following extensive exposure to hydrazine sulfate.
Special Point
- Hydrazine sulfate is commercially available in the United States, but it is illegal to use it as a cancer therapy.
Dosage (Inside MSKCC Only)
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