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 range
1 Year – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. Unable or unwilling to discontinue consuming prohibited soy-based food or supplements while participating in this study
. Pre-existing neutropenia or neutrophil qualitative or quantitative disorder
. Pre-existing cytopenia or bone marrow failure syndrome
. History of gastric or duodenal ulcers or hyperacidity syndromes
. History of Human Immunodeficiency Virus (HIV)
. Has an active infection requiring systemic therapy
. Planned treatment does not include myelosuppressive chemotherapy