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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
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Glucosamine Chondroitin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: May 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Glucosamine Chondroitin
 Drug: Glucosamine Chondroitin
Glucosamine [500mg three times daily (TID) x 24 weeks] plus chondroitin (400mg TID x 24 weeks)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691678

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Dawn L. Hershman
Investigators
Principal Investigator: Dawn Hershman, MD Columbia University
  More Information

No publications provided

Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00691678     History of Changes
Other Study ID Numbers: AAAC8748
Study First Received: June 3, 2008
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
breast cancer
aromatase inhibitor
supportive care

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013