Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients
- 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
- 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
- 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)
- 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
- 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%.