Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
ClinicalTrials.gov Identifier:
NCT00691678
First received: June 3, 2008
Last updated: February 19, 2013
Last verified: February 2013

June 3, 2008
February 19, 2013
May 2008
July 2012   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
Drug: Glucosamine Chondroitin
Glucosamine [500mg three times daily (TID) x 24 weeks] plus chondroitin (400mg TID x 24 weeks)
Experimental: I
Glucosamine Chondroitin
Intervention: Drug: Glucosamine Chondroitin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2012
July 2012   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00691678
AAAC8748
Yes
Dawn L. Hershman, Columbia University
Dawn L. Hershman
Not Provided
Principal Investigator: Dawn Hershman, MD Columbia University
Columbia University
February 2013

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