
AE-941/Neovastat was administered in a randomised phase III trial of BeneFin including 331 patients with advanced solid tumours (including lung, prostate, breast, and kidney tumours).3 They were randomly assigned to receive either 30 to 240 mL/day cartilage or a placebo divided into three to four oral doses a day. Survival was the principal endpoint measured in this trial, but quality of life was also assessed. The results of these trials, however, have not been fully reported. A retrospective analysis involving a subgroup of patients with advanced non-small cell lung cancer suggests that AE-941/Neovastat is able to lengthen the survival of patients with this disease.
Two randomized phase III trials of AE-941/Neovastat in patients with advanced cancer have been approved by the United States Food and Drug Administration (FDA). In one trial in patients with stage III non-small cell lung cancer, treatment with oral AE-941/Neovastat plus chemotherapy and radiation therapy was compared to treatment with placebo plus the same chemotherapy and radiation therapy. Overall survival was not improved in patients taking the shark cartilage preparation 20 In the second trial, treatment with oral AE-941/Neovastat was compared to treatment with placebo in patients with metastatic renal cell carcinoma.21 Results from this second phase III trial have not been reported in the peer-reviewed literature.
Loprinzi published a double-blind, placebo-controlled randomised clinical trial of adjuvant therapy with shark cartilage administered three to four times daily to 83 patients with incurable breast or colorectal cancers.22 The primary endpoint, survival, showed no difference between the patients receiving shark cartilage and those receiving placebo in addition to standard care. Similarly, quality of life showed no inter-group differences.
Another randomised trial suggested an anti-angiogenic effects of shark cartilage in healthy volunteers.23
Several uncontrolled clinical studies have been published, which suggest anti-cancer effects of shark cartilage.24-31 The results of these studies tend to imply that shark cartilage is effective in changing the natural history of various types of cancer or positively influencing related variables. Yet, due to their uncontrolled nature, these investigations cannot establish cause and effect.
Some basic research studies have suggested direct toxicity against tumour cells. The inhibition of tumour angiogenesis has been relatively well documented in in-vitro studies One study, for instance, found that tamoxifen has significant anti-angiogenic activity that can be potentiated by shark cartilage.32
Another laboratory study suggested that the development of papillary and solid tumours in mice can be significantly delayed.25
Most recent update and revision in November 2011 by Edzard Ernst.
Fully revised and updated in April 2010 by Edzard Ernst.
Summary first published in September 2005, authored by Edzard Ernst.