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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769990
Recruitment Status : Withdrawn (No patient accrual.)
First Posted : October 9, 2008
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief 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.

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

Detailed Description:


  • 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)
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
Study Start Date : September 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : April 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Safety [ Time Frame: At completion of first 6 patients ]
    Frequency of severe (grade 3) toxicities

Secondary Outcome Measures :
  1. Time to pain relief, duration of pain relief, and degree of pain relief
  2. Incidence of pathologic fractures
  3. Effect of treatment on quality of life measures as assessed by the BPI and FACT-G

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed malignant solid tumor, including any of the following:

    • Breast cancer
    • Lung cancer
    • Kidney cancer
    • Melanoma
    • Prostate cancer
  • Radiographic evidence* of bone metastasis within the past 8 weeks NOTE: *Acceptable studies include plain radiograph, radionuclide bone scan, CT scan, and MRI
  • 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

    • "Worst pain score" of > 5 on a scale of 10 as scored on the pain assessment questionnaire (BPI) (question #3: 0 = no pain; 10 = worst possible pain) OR taking narcotic medications with an oral morphine equivalent dose of > 60 mg/day
    • No painful metastases to the skull, hands, or feet
  • Eligible treatment sites include any of following:

    • Weight-bearing sites:

      • Pelvis (excluding pubis)
      • Femur
      • Sacrum and/or sacroiliac joints
      • Tibia
    • Non-weight-bearing sites:

      • Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
      • Lumbosacral spine
      • Up to 3 consecutive ribs
      • Humerus
      • Fibula
      • Radius ± ulna
      • Clavicle
      • Sternum
      • Scapula
      • Pubis
  • 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

    • Treatment of multiple osseous sites allowed only if those sites can be included in ≤ 3 treatment sites
  • Patients with painful metastases that are contiguous but do not fit into the definition of a site listed above are eligible but are considered to have 2 treatment sites
  • No vertebral metastases with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
  • No primary hematologic malignancies (e.g., lymphoma)
  • Hormone receptor status (for patients with breast cancer):

    • Estrogen receptor-negative tumor
  • Menopausal status not specified
  • Karnofsky performance status 40-100%
  • Life expectancy ≥ 3 months
  • ALT normal
  • Bilirubin normal
  • Serum creatinine normal (≤ 1.8 mg/dL for males and ≤ 1.5 mg/dL for females)
  • Free T4 and thyroid-stimulating hormone normal
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pathologic fracture or impending fracture of the treatment site
  • No history of primary hyperparathyroidism
  • No malabsorptive disease or chronic diarrhea
  • No history of sarcoidosis or tuberculosis

Exclusion Criteria:

  • Less than 30 days since prior systemic radioisotopes for pain, including Strontium-90 (^90Sr) or Samarium (^153Sm)
  • Less than 30 days since prior antibiotics
  • Less than 30 days since prior initiation of systemic therapy (e.g., hormonal therapy, chemotherapy, or immunotherapy)
  • Less than 90 days since prior intravenous bisphosphonate therapy

    • Concurrent oral bisphosphonates allowed
  • Prior radiotherapy or palliative surgery to the painful sites
  • Concurrent surgical fixation of the bone
  • Concurrent treatment to the skull, hands, or feet

Information from the National Library of Medicine

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 identifier (NCT number): NCT00769990

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Principal Investigator: Shalamar Sibley, MD, MPH Masonic Cancer Center, University of Minnesota

Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00769990     History of Changes
Other Study ID Numbers: 2008LS035
UMN-0803M29541 ( Other Identifier: IRB, University of Minnesota )
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: July 2011

Keywords provided by Masonic Cancer Center, University of Minnesota:
bone metastases
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

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Kidney Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Kidney Diseases
Urologic Diseases