Spots Global Cancer Trial Database for Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases

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

Study ID: NCT00769990

Conditions

Interventions

genistein

radiation therapy

Study Description

Brief 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.

Detailed 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.