Phase I Trial with an Isoflavonoid Rich Soy/Milk/Honey Supportive Nutrition for Including Into Therapy-Optimizing-Protocols in Oncology

Summary

A Phase I study was carried out with an isoflavonoid rich soy/milk/honey product (Somisan®) with the purpose to evaluate the efficacy of such a product for further inclusion into therapy-optimising- studies (TOS). According to a modified Fibonacci-scheme, no adverse side effects, allergy or atopy occurred in 20 subjects enrolled. The optimal dosage was determined with 50 g to 75 g of Somisan®. This dose range caused individual serum levels of diphenolic phyto-oestrogens, like genistein and daidzein, close to that, which are common in Asian people consuming regularly soybean products (Tofu, Miso paste). From epidemiological studies it is well known that Asian compared to Western people do have a lower risk for some tumor entities, like prostate or breast cancer, which can be correlated to the natural diet, rich in isoflavonoids. Laboratory studies clearly indicate that genistein and daidzein do have molecular targets, when blocked, inhibit tumor growth. Therefore, it is consequent to support successful anti-tumor protocols by diets, the ingredients of which are known not to interact with or to diminish the cytotoxic principles, but deliver tumor inhibiting or preventing substances with no adverse side effects. The Phase I results suggest that Somisan® is a candidate to be studied in TOS for further improvement of successful anti-tumor- protocols in respect to quality of life, lowering of toxic side effects, increasing response rates and prolongation of disease-free survival.

Keywords

Soybean products - therapy-optimising-studies (TOS) - isoflavonoids

References

• 01 Van Eys J.. Effects of nutritional status on response to therapy.  Cancer Res.. 42 ((suppl.)) 1982;  747-753
• 02 Hansell D. T., Davies J. W. L., Burns H. J. G.. The effects on resting energy expenditure of different tumor types.  Cancer. 58 1986;  1739-1744
• 03 Tisdale M. J.. Cancer cachexia.  Br. J. Cancer. 63 1991;  337-342
• 04 Zänker K. S., Daftary G. V., Gottschalk G., Adlercreutz H.. Genistein and daidzein: Mode of action and bioavailability in a soy-enriched diet.  Dtsch. Ztschr. Onkol.. 33 2001;  37-44
• 05 Adlercreutz H., Mazur W.. Phyto-oestrogens and Western Diseases.  Ann. Med.. 29 1997;  95-120
• 06 Price K. R., Fenwick G. R.. Naturally occurring oestrogens in foods - a review.  Food Addict. Contam.. 2 1985;  73-106
• 07 Peterson G., Barnes S.. Genistein inhibition of the growth of human breast cancer cells - independence form estrogen receptors and the multi-drug resistence gene.  Biochem. Biophys. Res. Commun. 179 1991;  661-667
• 08 Kennedy A. R.. The evidence for soybean products as cancer preventive agents.  J. Nutr.. 125 1995;  733-743
• 09 Niederprüm H. J., Schweikert H. U., Thüroff J. W., Zänker K. S.. Inhibition of steriod 5-alpha-reductase by specific aliphatic fatty acids. - Candidates for chemoprevention of prostate cancer.  Ann. N.Y. Acad. Sci.. 768 1995;  227-231
• 10 Teicher B. A., Holden S. A., Ara G., Korbut T., Menon K.. Comparison of several antiangiogenic regimens alone and with cytotoxic therapies in the Lewis lung carcinoma. Cancer Chemother.  Pharmacol.. 38 1996;  169-177
• 11 Zänker K. S., Kubens B. S.. Chemoprävention in der Onkologie: Von der Ernährung zum präventiven Molekül und zu klinischen Studien.  Der Onkologe (im Druck).

Correspondence to: