What
is hydrazine sulfate?
Hydrazine
sulfate is
a compound that
has been studied as a treatment for cancer and for
cancer-related anorexia (loss of appetite)
and cachexia (loss
of muscle mass and body weight).
What
is the history of the discovery and use of hydrazine sulfate as a
complementary or alternative treatment for cancer?
It
has been known since the early 1900s that hydrazine compounds are toxic to
animals and to humans. More than 400 hydrazine-related compounds have
been tested for their ability to kill cancer cells.
One of these compounds, procarbazine,
has been used to treat Hodgkin
disease, melanoma,
and lung
cancer since
the 1960s.
In
view of procarbazine’s anticancer activity, hydrazine sulfate (a
compound similar to procarbazine) was studied for its effectiveness in
fighting cancer beginning in the 1970s. Studies of hydrazine sulfate as
a treatment for cancer-related cachexia also began during this time.
Hydrazine
compounds have also been used to make rocket fuel, as herbicides(chemicals that
kill plants), and as chemical agents in boiler and cooling-tower water
systems. Many scientists consider
hydrazine sulfate and other similar substances to be cancer-causing
agents and are concerned about the safety of using these compounds.
What
is the theory behind the claim that hydrazine sulfate is useful in
treating cancer?
Two
theories have been suggested to explain how hydrazine sulfate acts
against cancer and cachexia:
- Hydrazine
sulfate may prevent the body from making sugar that cancer cells need
to grow. It has been suggested that cachexia occurs because the cancer
is using too much of the body's sugar, preventing healthy cells from
getting what they need to live. This causes tissues to die
and muscle to waste away, and the patient loses weight.
- Hydrazine
sulfate may block tumor
necrosis factor-alpha (TNF-alpha).
This is a substance made by the body’s white
blood cells to
fight infection and
tissue damage. High levels of TNF-alpha have been found in cancer
patients. These high levels of TNF-alpha may cause loss of appetite,
tiredness, and the breakdown of muscle tissue. As muscle breaks down,
it makes sugar that the cancer cells use to grow. Blocking the
TNF-alpha might stop tumor growth
and prevent cachexia.
How
is hydrazine sulfate administered?
Hydrazine
sulfate is taken by mouth in pills or capsules.
There is no standard dose or
length of treatment time.
Have
any preclinical (laboratory or animal) studies been conducted using
hydrazine sulfate?
Research
in a laboratory or using animals is done to find out if a drug,
procedure, or treatment is likely to be safe and useful in humans. These preclinical
studies are
done before any testing in humans is begun. The following has been
learned from preclinical studies of hydrazine sulfate:
- In
most studies with rats, mice, and hamsters, hydrazine sulfate caused an
increase in lung, liver,
and breast cancers.
- When
used alone against certain types of cancer (including melanoma, leukemia, bladder,
breast, and prostate),
hydrazine sulfate slowed tumor growth in some animal
studies and
showed no effect in others. In cases where tumor growth was slowed the
most, the animals lost large amounts of weight. This finding does not
support the proposed use of hydrazine sulfate to treat cachexia caused
by cancer.
- When
hydrazine sulfate was combined with an anticancer drug, it seemed to
improve the anticancer effects in rats and mice. When hydrazine sulfate
was combined with an anticancer drug that affects the way cells use
sugar, however, it helped in some studies and did not help in others.
- Preclinical
studies by the National
Cancer Institute (NCI)
found that hydrazine sulfate showed no anticancer activity except in
one type of cancer in rats. The NCI decided not to continue studying
the compound as a treatment for cancer. Studies of hydrazine sulfate as
a treatment for cancer-related anorexia and cachexia continued.
For
more information on the preclinical studies, see the PDQ health
professional version of Hydrazine
Sulfate.
Have
any clinical trials (research studies with people) of hydrazine sulfate
been conducted?
Clinical
trials are
a type of research
study that
tests how well new drugs or other treatments work in people. There have
been many studies of hydrazine sulfate in patients with advanced
cancer. Researchers looked at the following:
- Tumor response and/or survival among
patients with various types of cancer.
- Changes
in body weight.
- Quality
of life.
- Changes
in nutritional
status and metabolism (chemical
changes that take place in cells and make energy needed for life).
Clinical
trials of hydrazine sulfate have reported the following:
- In
the mid 1970s, clinical trials by a drug company found that a small
number of patients who were treated with hydrazine sulfate for advanced
cancer reported having a better appetite, losing less weight, feeling
stronger, or having less pain. In some patients, the tumor got smaller
or did not grow, or there was improvement in a cancer-related symptom.
These clinical trials do not prove that hydrazine sulfate is effective
for advanced cancer, however, because of weaknesses in study design.
There was no control
group (a
group of patients who did not receive hydrazine sulfate) and half of
the patients in the trial could not be counted in the results for
reasons that include missing information, short treatment times, and
receiving other treatment along with the hydrazine sulfate.
- From
the 1970s to the mid 1990s, Russian studies with hydrazine sulfate had
mixed results. Little information was reported about the patients and
their treatment and about the study design and methods. All of the
patients in these studies also received standard
treatment with surgery, chemotherapy,
and/or radiation
therapy. Therefore, it is not known if results were caused
by hydrazine sulfate or one of the standard treatments, or both.
- Clinical
studies funded by the NCI in the 1970s found that hydrazine sulfate did
not cause tumors to shrink or go away. Some patients reported small
improvements in appetite, pain, and weight, but they did not last.
These studies did not include control groups.
- Four randomized controlled
trials were
done in the 1990s. A randomized trial is a study in which the patients
are assigned by chance to separate groups to compare different
treatments; neither the researchers nor the patients can choose which
group. These trials compared hydrazine sulfate with a placebo (an
inactive substance that looks like the treatment being tested). The
results showed that hydrazine sulfate was not effective in treating
cancer. In some cases, it was found to be harmful.
- In
three of the trials, lung cancer patients received either hydrazine
sulfate or a placebo, along with anticancer drugs. The patients who
received hydrazine sulfate did not live longer or have their tumors
shrink any more than the placebo group. In one of the studies, patients
who took hydrazine sulfate showed better nutritional
status than
patients in the placebo group, although the increase in body weight was
small. In another of the studies, patients who received hydrazine
sulfate had a worse quality of life than patients who received the same
anticancer drugs plus the placebo. [1]
- A
fourth trial found that patients with colorectal
cancer who
received only hydrazine sulfate lived for a shorter time than patients
who received only a placebo.
- Four
other randomized controlled trials studied the effects of hydrazine
sulfate on nutritional status and metabolism. The studies showed some
benefit from hydrazine sulfate.
- In
2 of the studies[2],
patients receiving hydrazine sulfate showed improvement in metabolism,
appetite, and in either gaining weight or not losing weight.
- In
the other 2 clinical trials[3],
lung and colon
cancer patients
receiving hydrazine sulfate had less cancer-related muscle
wasting.
Have
any side effects or risks been reported from hydrazine sulfate?
In
general, the reported side
effects of
hydrazine sulfate treatment have been mild to moderate. Most side
effects are reported to end when treatment with hydrazine sulfate is
stopped. Some animal studies, however, suggest that hydrazine sulfate
may be highly toxic (harmful) when combined with either alcohol or barbiturates (drugs
with sedative and hypnotic effects).
Most
of the side effects caused by hydrazine sulfate have involved the nervous
systemand gastrointestinal
tract. These side effects include the following:
- Nausea and/or vomiting.
- Dizziness.
- Abnormal feelings
in the arms and legs (such as burning or prickling).
- Nerve inflammation.
- Impaired fine motor function
(such as trouble writing).
- Dry
skin and/or itching.
- Being
unable to sleep.
- Abnormally
low blood
sugar.
One
case of fatal liver and kidney
failure and
one case of severe injury to the brain have been linked to the use of
hydrazine sulfate.
Is
hydrazine sulfate approved by the U.S. Food and Drug Administration
(FDA) for use as a cancer treatment in the United States?
The FDA has not
approved hydrazine sulfate for use as a cancer treatment in the United
States.
The
FDA has approved the study of hydrazine sulfate in clinical trials.
Information about ongoing clinical trials can be found on the NCI
website.
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supplements are products meant to be added to the diet.
They are not drugs and are not meant to treat, prevent, or cure diseases.
The manufacturer is responsible for ensuring that the product is safe
and that the label claims are truthful and not misleading. The FDA does
not approve dietary supplements as safe or effective before they are
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