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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00769990 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Kidney Cancer Lung Cancer Melanoma Metastatic Cancer Pain Prostate Cancer |
Dietary Supplement: genistein Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 0 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Genistein
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: Bonistein
Radiation: radiation therapy
A course of palliative external beam radiation therapy -performed within 8 weeks prior to start of the study.
|
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed malignant solid tumor, including any of the following:
Has pain that appears to be related to the radiographically documented metastasis, in the opinion of the treating physician, AND a decision has been made by the responsible clinician that a course of palliative external beam radiotherapy is appropriate treatment
Eligible treatment sites include any of following:
Weight-bearing sites:
Non-weight-bearing sites:
If multiple osseous sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur, or tibia
Hormone receptor status (for patients with breast cancer):
Exclusion Criteria:
Less than 90 days since prior intravenous bisphosphonate therapy
Contacts and Locations
More Information
| Responsible Party: | Shalamar Sibley, Masonic Cancer Center at University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00769990 History of Changes |
| Other Study ID Numbers: | 2008LS035, UMN-0803M29541 |
| Study First Received: | October 8, 2008 |
| Last Updated: | July 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
bone metastases pain recurrent breast cancer stage IV breast cancer recurrent prostate cancer stage IV prostate cancer recurrent melanoma |
stage IV melanoma recurrent renal cell cancer stage IV renal cell cancer recurrent non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer |
|
Breast Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Lung Neoplasms Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes |