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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00769990 |
RATIONALE: Cholecalciferol and 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 giving cholecalciferol together with 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 |
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Breast Cancer Kidney Cancer Lung Cancer Melanoma (Skin) Metastatic Cancer Pain Prostate Cancer |
Dietary Supplement: cholecalciferol Dietary Supplement: genistein Other: questionnaire administration Procedure: pain therapy Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Active Control |
Official Title: | Phase I-II Trial of Vitamin D (Cholecalciferol) and Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo external beam radiotherapy once daily on days 1-10. Patients also receive oral cholecalciferol and 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
Veterans Affairs Medical Center - Minneapolis | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Shalamar Sibley, MD, MPH | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Shalamar Sibley ) |
Study ID Numbers: | CDR0000615124, UMN-2008LS035, UMN-0803M29541 |
Study First Received: | October 8, 2008 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00769990 History of Changes |
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 |
Anticarcinogenic Agents Thoracic Neoplasms Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Bone Density Conservation Agents Urologic Neoplasms Protein Kinase Inhibitors Hormones Lung Neoplasms Neoplasm Metastasis Neuroepithelioma Kidney Diseases Breast Diseases |
Cholecalciferol Breast Neoplasms Genital Diseases, Male Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Vitamin D Lung Diseases Nevus Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Urinary Tract Neoplasm Genital Neoplasms, Male Quality of Life |
Thoracic Neoplasms Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Prostatic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Bone Density Conservation Agents Urologic Neoplasms Protein Kinase Inhibitors Hormones Neoplasms by Site Pathologic Processes Lung Neoplasms Therapeutic Uses |
Neoplasm Metastasis Kidney Diseases Breast Diseases Cholecalciferol Breast Neoplasms Genital Diseases, Male Carcinoma Neuroectodermal Tumors Neoplasms Lung Diseases Prostatic Neoplasms Neoplasms, Glandular and Epithelial Genital Neoplasms, Male Antineoplastic Agents Neoplasms, Nerve Tissue |