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15.1
Soy phytoestrogens (SOYEST)
15.11
Preparation and storage
The
SOYEST tablet we are utilizing in this protocol is made
from a powder that is a pure product derived from soybeans.
Each 600 mg tablet contains 50 mg of isoflavones. The isoflavones
consist primarily of 45% daidzein and daidzin isoforms,
46% genistein and genistin isoforms, and 10% glycitein and
glycitin isoforms. The tablets can be stored at room temperature.
The isoflavone concentrate used to make the tablets has
been stored in a 70% relative humidity 40°C chamber for
9 months without any apparent isoflavone loss.
The
other ingredients in the tablet (in addition to the soy
isoflavone powder) are dicalcium phosphate, sorbitol (10%),
and a very small amount of magnesium stearate (0.5%).
15.12
Potential toxicities
No serious toxicities are expected. The amount of isoflavones
that will be in each tablet will be similar to that which
would be ingested with a glass of soybean milk. This current
product is considered a food substance as opposed to a drug.
As with any product, however, there is always a possibility
of an allergic reaction (patients with known soy allergies
will be excluded from this study). Flatulence and bloating
may occur with some soy products but the products known
to cause these symptoms are not present in any appreciable
amounts in the tablets we are utilizing. We will monitor
patients for allergic reactions, flatulence, bloating, diarrhea,
nausea, and vomiting.
15.13
Medication procurement - The NCCTG research base pharmacist
will obtain the medication and placebo from Archer Daniels
Midland Company (Decatur, IL). Each institution will order
the medication from the NCCTG research base pharmacist.
Submit the NCCTG Clinical Drug Order/Return
Form request to:
Medical Oncology Pharmacist
Mayo Clinic Mayo Building, E-12
Rochester, MN 55555
FAX (555) 555-5555
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