Breast Cancer Clinical Trial
Official title:
Phase I-II Trial of Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
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.
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