The wheat germ extract is an applicable complex of multiple, biologically active molecules. Preclinical studies suggest potent anti-metastatic activity and it has a favorable toxicity profile. It has been aimed in a pilot-scale, phase II clinical study to document whether or not wheat germ extract as a support to surgery or plus chemotherapy adds any therapeutic benefit compared to the same combination without wheat germ extract in colorectal cancer.

From 1998 to June 1999, 18 control patients and 12 consecutive colorectal cancer patients respectively, were enrolled into this study. All patients underwent curative surgery. The control group (18 patients) received no other therapy or adjuvant chemotherapy alone. The wheat germ extract group (12 patients) received wheat germ extract alone or plus adjuvant chemotherapy. Until now, the median follow-up has been 9 months.

Interim data of the study document that in the wheat germ extract group no new metastases, neither hepatic nor other, have occurred, so far. On the contrary, several new metastases have developed in the control group.

Orally administered wheat germ extract is a potent candidate to be regarded as a supportive therapy to surgery or plus chemotherapy for colorectal cancer patients.

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