Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) (NCT02624388) | Clinical Trial Compass
TerminatedPhase 2
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
Stopped: Poor enrollment
United States4 participantsStarted 2016-08
Plain-language 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.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed solid tumor or lymphoma with histological verification
✓. Age 1 - 21 years at time of diagnosis
✓. Karnofsky/Lanksy performance score of ≥ 50
✓. Able to tolerate enteral medication administration
✓. Planned chemotherapeutic regimen for a patient must meet all of the following criteria:
✓. Informed consent or parental permission and assent obtained prior to trial-related activities
✓. Able and willing to comply with all study related procedures
✓. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Exclusion criteria
✕. Known allergy to soy or any soy-based food or supplement
What they're measuring
1
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays