Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00691678

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	Dietary Supplement: Glucosamine Chondroitin	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Glucosamine hydrochloride Translagen Glucosamine sulfate Glucosamine Chondroitin Chondroitin sulfates

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 ]

Estimated Enrollment:	53
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Glucosamine Chondroitin	Dietary Supplement: Glucosamine Chondroitin Glucosamine [500mg three times daily (TID) x 24 weeks] plus chondroitin (400mg TID x 24 weeks)

Eligibility

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

Contacts

Contact: Dawn L Hershman, MD

212-305-1945

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Principal Investigator: Dawn L Hershman, MD

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Dawn Hershman, MD

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University ( Dawn Hershman )
Study ID Numbers:	IRB-AAAC8748
Study First Received:	June 3, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00691678 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Columbia University:

breast cancer
aromatase inhibitor
supportive care

Study placed in the following topic categories:

Chondroitin
Skin Diseases
Glucosamine

Breast Neoplasms
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Breast Neoplasms

Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on July 06, 2009