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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014