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Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
This study is currently recruiting participants.
Study NCT00691678   Information provided by Columbia University
First Received: June 3, 2008   Last Updated: February 2, 2009   History of Changes

June 3, 2008
February 2, 2009
May 2008
January 2011   (final data collection date for primary outcome measure)
Change in Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria (composite endpoint including pain, function, and the patient's global assessment of disease) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00691678 on ClinicalTrials.gov Archive Site
 
 
 
Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients

Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors

 
Phase II
Interventional
Supportive Care, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Breast Cancer
Dietary Supplement: Glucosamine Chondroitin
Experimental: Glucosamine Chondroitin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
53
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >21 years
  • Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL
  • History of stage I, II or IIIA hormone receptor-positive breast cancer, without metastatic disease
  • Currently taking a third-generation aromatase inhibitor for at least 3 months
  • Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry
  • Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.
  • patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study
  • If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study.
  • ECOG performance status 0-2.
  • Hemoglobin A1c <8.
  • Signed informed consent

Exclusion Criteria:

  • se of glucosamine or chondroitin within the past six months
  • Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including:

    • Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica)
    • gout
    • episodes of acute monarticular arthritis clinically consistent with pseudogout
    • Paget's disease affecting the study joint
    • a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint
    • Wilson's disease
    • hemochromatosis
    • alkaptonuria
    • primary osteochondromatosis
  • History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
  • History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
  • AST, ALT > 2x normal.
  • Serum Creatinine of > 1.8 mg/dl.
  • Uncontrolled hypertension (Systolic Blood Pressure of > 150 mm Hg or Diastolic Blood Pressure of >95 mm Hg).
  • Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.
Female
21 Years and older
No
Contact: Dawn L Hershman, MD 212-305-1945 dlh23@columbia.edu
United States
 
NCT00691678
Dawn Hershman, Columbia University
IRB-AAAC8748
Columbia University
 
Principal Investigator: Dawn Hershman, MD Columbia University
Columbia University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP