Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Toxicities related to pediatric cancer treatment can lead to significant illness, organ
damage, treatment delays, increased health care cost, and decrease in quality of life. Such
toxicities are largely due to tissue damage sustained by chemotherapy, and strategies
designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity
and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally
occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been
shown to reduce side effects of therapy in adult oncology clinical trials. This study will
examine the effect of genistein, the major isoflavone component in soybeans and the most
extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive
chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a)
30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy
Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein
daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have
fewer short-term therapy-related side effects during cycles of chemotherapy given in
conjunction with genistein supplementation than cycles given with placebo.