RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain caused by bone metastases. PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well it works in treating patients undergoing external-beam radiation therapy for pain caused by bone metastases.
OBJECTIVES: * To determine whether genistein is safe when administered in combination with palliative external beam radiotherapy in patients with osseous metastases. * To determine the time to pain relief, duration of pain relief, and degree of pain relief in patients treated with this regimen. * To determine the incidence of pathologic fractures in patients treated with this regimen. * To determine the effect of this regimen on quality of life measures in these patients. OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy once daily on days 1-10. Patients also receive oral genistein once daily on days 1-60. Patients complete pain and quality-of-life questionnaires periodically. After completion of study therapy, patients are followed at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.
Safety
Frequency of severe (grade 3) toxicities
Time frame: At completion of first 6 patients
Time to pain relief, duration of pain relief, and degree of pain relief
Incidence of pathologic fractures
Effect of treatment on quality of life measures as assessed by the BPI and FACT-G
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