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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT00769990
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2008
Completion date April 2010

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