Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
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|ClinicalTrials.gov Identifier: NCT00769990|
Recruitment Status : Withdrawn (No patient accrual.)
First Posted : October 9, 2008
Last Update Posted : December 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Kidney Cancer Lung Cancer Melanoma Metastatic Cancer Pain Prostate Cancer||Dietary Supplement: genistein Radiation: radiation therapy||Phase 1 Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||April 2010|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769990
|Principal Investigator:||Shalamar Sibley, MD, MPH||Masonic Cancer Center, University of Minnesota|