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

Phase 2
21 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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%.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

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)

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Dawn Hershman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

July 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • aromatase inhibitor
  • supportive care
  • Breast Neoplasms



Columbia UniversityNew York, New York  10032-3784