This randomized pilot clinical trial studies how well genistein works in reducing the side effects of chemotherapy in pediatric patients with solid tumors or lymphoma. Genistein may help reduce the side effects of chemotherapy by reducing cell damage, making sick cells more likely to die, preventing cancer growth, and making cancer cells more responsive to chemotherapy.
Additional locations may be listed on ClinicalTrials.gov for NCT02624388.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To estimate the effect of supplementation with genistein on the time to neutrophil count recovery following myelosuppressive chemotherapy.
SECONDARY OBJECTIVES:
I. To estimate the effect of supplementation with genistein on short-term side effects of myelosuppressive chemotherapy.
II. To estimate levels of the serum markers of inflammation during cycles of chemotherapy given in conjunction with genistein supplementation versus placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive genistein orally (PO) daily for courses 1-2 and placebo PO daily for courses 3-4. Treatment repeats every 14 or 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive placebo PO daily for courses 1-2 and genistein PO daily for courses 3-4. Treatment repeats every 14 or 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 35 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorWilliam Carl Petersen
