About Herbs

Bottom Line: Germanium (also called spirogermanium) is NOT an effective treatment for cancer, HIV, or any other medical condition. It has caused severe side effects and death in several patients.

Germanium is a naturally occurring element that can be found in foods such as shittake mushrooms, garlic, tuna, and tomato juice. It is not classified as an essential nutrient for human health, but it is actually not known whether the body's physiological processes require germanium. No humans have ever suffered from germanium deficiency, indicating that it may not be essential. Germanium may be an antioxidant, neutralizing free radicals that can damage DNA and cells. In laboratory experiments, a derivative of germanium called spirogermanium has been shown to inhibit replication in certain cancer cells, but this anti-cancer activity has not been shown in human studies.

Cancer treatment:
In the early 1980s, several clinical trials tested germanium against various cancers. A large number of patients in these trials developed serious toxic side effects such as kidney, liver, and nerve damage. At the present time, nine people have died from the toxic effects of germanium supplements.

In 1984, a phase I trial was conducted to find the highest dose of intravenous germanium that could be given to cancer patients without toxic side effects. Fifteen patients with various cancers (leukemia, lymphoma, Hodgkin's disease, ovarian, colon, lung, and head/neck) enrolled in the study. All of the doses, even the lowest, caused toxic side effects, including phlebitis (vein inflammation) and neurologic effects (stuttering, confusion, tremors, and hallucinations). None of the patients experienced improvement of their condition while taking germanium, indicating that treatment with this supplement may not be worth its toxic effects.

The Eastern Cooperative Oncology Group (ECOG) conducted a clinical trial of germanium in the treatment of lymphoma or Hodgkin's disease in 1986. Twenty-five patients enrolled; all had undergone at least one prior course of chemotherapy. The patients received 80 mg/m² of spirogermanium intravenously three times a week for two weeks. Cancer progressed in most patients within a few weeks. Toxic side effects were common, which prompted the ECOG to recommend that no future studies be conducted with germanium.

Inorganic germanium, germanium dioxide (GeO2), spirogermanium, carboxyethylgermanium sesquioxide (Ge-132), germanium sesquioxide, germanium-lactate-citrate (Ge-lac-cit), organogermanium, germanium elixir

Germanium is a naturally occurring element. It is promoted for treating cancer, HIV, and AIDS. Supplementation with germanium has resulted in renal, hepatic, myelogenous, and neurologic toxicities. To date, 9 deaths have been reported in the literature from as little as 15 grams cumulative dose ^{(2) (3) (6) (7)}. Limited clinical research has been conducted in humans. The toxicity risk from germanium supplements outweighs any benefit.

Shittake mushrooms, garlic, tuna, pan fish, tomato juice
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Germanium has chemical properties similar to tin, silicon, and arsenic. It is unknown whether germanium is an essential ultra-trace element for humans; no cases of germanium deficiency are known to have occurred. The atomic structure of germanium allows it to act as a free-radical scavenger ⁽¹⁾. Neuronal activity may be due to suppression of catecholamines and stimulation of serotonin. Spirogermanium has been shown to inhibit DNA and RNA synthesis in HeLa cells ⁽²⁾.

Absorption:
Oral administration of germanium dioxide (GeO₂) to rats demonstrates approximately 95% bioavailability. Organic radiolabeled germanium (Ge-132) has repeatedly been shown to have 30% bioavailability in humans and animal models.
Distribution:
Extensive throughout body, but detectable levels in tissue vary based on dose and frequency of administration. Can be detected in blood, lung, and spleen with preferential accumulation in liver and kidneys.
Elimination:
Excreted primarily by the kidneys.
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Germanium supplements should not be consumed due to concerns of renal, hepatic, and neurotoxicity. Although acute toxicity studies in animals reveal low potential for toxicity, low-dose chronic toxicity has been demonstrated repeatedly. Renal toxicity is characterized by vacuolar degeneration in renal tubular epithelial cells, without proteinuria or hematuria, in the absence of glomerular changes ^{(2) (7)}.

Patients with a history of seizures should not take germanium.

Common: Weight loss, fatigue, nausea, vomiting, anorexia, anemia, muscle weakness, paresthesias, and sensory ataxia ⁽¹⁾.
Rare: Chronic renal failure, elevated liver enzymes, hepatic steatosis, peripheral neuropathies, cerebellar ataxia, and bone marrow hypoplasia ^{(4) (5) (6)}.

Theoretically, may have additive toxicity with other drugs known to cause renal (e.g. aminoglycosides), hepatic, or neurotoxicity (e.g. taxanes), or myelosuppression.

Elevated liver enzymes, increased serum creatinine, decreased blood counts, and elevated creatinine phospho kinase (CPK).

Many clinical trials evaluating spirogermanium for various cancers were conducted in the early 1980s. A significant incidence of renal, hepatic, and neurological toxicity was documented. To date, 31 case reports of toxicity, including 9 deaths, have been published.

Woolley PV, et al. A phase I trial of spirogermanium administered on a continuous infusion schedule. Invest New Drugs 1984;2:305-9.
Fifteen patients with various oncologic diagnoses (2 leukemia, 4 lymphoma, 1 Hodgkin's, 4 ovarian, 2 colon, 1 lung, 1 head/neck) and extensive prior chemotherapy were included in this dose ranging study. Adverse effects were documented at all dosing levels ranging from phlebitis at lowest dose (up to 200 mg/m²/day) to neurologic effects (at 250 mg/m²/day) including stuttering, confusion, hallucinations, and peripheral phlebitis. Tremors were considered the dose-limiting toxicity at 400 mg/m²/day. Phlebitis was unresponsive to premedication with hydrocortisone. No clinical response was documented during the trial.

Boros L, et al. Phase II Eastern Cooperative Oncology Group study of spirogermanium in previously treated lymphoma. Cancer Treat Rep 1986;70:917-8.
A total 25 patients with malignant high or low-grade lymphoma or Hodgkin's disease were evaluated. All patients had received at least one prior chemotherapy regimen. Spirogermanium 80 mg/m² IV was administered over 60-90 minutes three times a week for two weeks. Therapy was continued until evidence of disease progression. Two partial responses were documented, one lasting 90 days (diffuse large cell lymphoma) and another lasting 7 months (diffuse poorly differentiated lymphocytic lymphoma). Two patients had stable disease lasting 4 and 8 months. Median time to disease progression was 19 days, and 23 patients died. Median survival from date of enrollment was 5 months (range of 6 days to 3 years). Toxicity included seizure (patient had history of seizures), paresthesia, tinnitus, lethargy, visual disturbances, insomnia, somnolence, vertigo, and headache. ECOG recommended to not initiate future studies with spirogermanium.