Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
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.
|Breast Cancer Kidney Cancer Lung Cancer Melanoma Metastatic Cancer Pain Prostate Cancer||Dietary Supplement: genistein Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: At completion of first 6 patients ]Frequency of severe (grade 3) toxicities
- 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
|Study Start Date:||September 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
Dietary Supplement: genistein
Genistein will be taken orally once daily as 500 mg capsules throughout the study (60 days).
Other Name: BonisteinRadiation: radiation therapy
A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769990
|Principal Investigator:||Shalamar Sibley, MD, MPH||Masonic Cancer Center, University of Minnesota|