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Shark cartilage has been researched for over 30 years.  Unfortunately, there are not many studies that have been published in peer-reviewed literature.  Additionally, there are only a handful of studies that have focused on the effect of shark cartilage on human subjects.

Three similar clinical studies of powdered shark cartilage have been presented at scientific conferences, but not yet published in peer-reviewed, scientific journals.  The three studies were phase II clinical trials that included patients with breast cancer (n=20), prostate cancer (n=12) and primary brain cancer (n=12).  The patients had been previously treated with conventional therapies that are standard for the particular malignancy.  The patients were not allowed be involved in any other therapy other than their daily dosage of shark cartilage.  Ten patients in each study completed the eight week course of shark cartilage therapy.  Two of the breast cancer patients had stable disease at 8 weeks.  Two patients with brain cancer and three patients with prostate cancer had stable disease that lasted 20+ weeks.  Obviously, these studies are not very significant considering the small number of patients involved. 

The safety and efficacy of Neovastat, the aqueous extract of shark cartilage, has also been investigated in clinical trials.  The results of one retrospective study suggest that Neovastat may be able to lengthen the survival of patients with non-small cell lung cancer.  There was no significant benefit to the patients with breast, prostate, or lung cancers.

A prospective analysis involving 22 patients with refractory renal cell carcinoma showed that patients treated with 240mL/day of Neovastat survived longer than patients treated with 60mL/day of Neovastat.  Again, the population size of this study is very small.

A study presented at the Second European Breast Cancer Conference concluded that shark cartilage is ineffective in breast cancer patients.  Dr. Lene Adrian of Copenhagen University Hospital tested shark cartilage on seventeen women with advanced breast cancer who had not responded to previously administered traditional therapies.  After taking 24 shark cartilage capsules a day for three months, fifteen of the women had progression of their breast cancer, and one women developed brain cancer.

In 2005 a study was preformed with the goal to determine whether shark cartilage improved overall survival for patients with advanced cancer who were receiving the standard of care. It was a randomized, double-blind, placebo-controlled, clinical trial that's subjects were patients with incurable breast or colorectal cancer. These patients were given the standard of care for their particular illness and than were randomly selected to receive either shark cartilage or placebo that was to be taken 3-4 times daily. The results showed that there was no difference in overall survival or quality of life between the patients taking the shark cartilage and those taking placebo. 

The FDA has approved several Phase III clinical trials.  One trial will be comparing patients with advanced cancer taking oral Neovastat plus chemotherapy and radiation therapy to patients taking a placebo plus the same chemotherapy and radiation therapy.  In another trial, treatment with Neovastat is being compared to treatment with placebo in patients with metastatic renal cell carcinoma.