NCT00769990

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Kidney Cancer
• Lung Cancer
• Melanoma
• Metastatic Cancer
• Pain
• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	genistein	Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
RADIATION	radiation therapy	A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2008-10-09
• Last updated: 2017-12-13