Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
Condition: Breast Cancer; Joint Pain
MeSH terms: Breast Neoplasms; Arthralgia
Intervention: Chondroitin; Glucosamine
Intervention description: 400mg chondroitin three times a day (TID) for twenty-four weeks; 500mg glucosamine TID for twenty-four weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: breast cancer; aromatase inhibitor; supportive care

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Age >21 years.

          -  Postmenopausal status defined as cessation of menses for >1 year or
             follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or
             bilateral oophorectomy.

          -  History of stage I, II or III 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, therefore it is recommended that routine bone density testing be
             performed prior to enrollment or after completing trial.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Hemoglobin A1c <8 within the last year.

          -  Signed informed consent.

        Exclusion Criteria:

          -  Use of glucosamine or chondroitin within the past three (3) months.

          -  Concurrent medical/arthritic disease that could confound or interfere with evaluation
             of pain or efficacy.

          -  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.

          -  Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.

          -  History of any illness that, in the opinion of the investigator, might confound the
             results of the study or pose additional risk to the patient.

          -  Allergy to, or history of significant clinical or laboratory adverse experience
             associated with acetaminophen, glucosamine or chondroitin sulfate.

          -  Allergy to shellfish.

          -  Inability to understand and complete study questionnaires including questions
             requiring a visual analog scale (VAS) response.

          -  Inability to understand the study procedures and/or give written informed consent.

          -  Alcohol use in excess of 3 mixed drinks/day.

          -  Corticosteroid treatment was used or administered.

          -  Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.

          -  Intra-articular injection of hyaluronic acid or congeners into the study joint within
             12 months.

          -  Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral
             analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and
             acetaminophen) within 2 weeks of baseline visit or during the study.

          -  Implementation of any other medical therapy for arthritis within one month prior to
             entry.

          -  Other medications, unrelated to the patient's joint pain/stiffness must have been used
             at a stable dosage for at least 1 month. In addition, it should be anticipated that
             the dose of the concomitant medication will be stable during the entire treatment
             period.

          -  Participation in another clinical study with an investigational agent within the last
             4 weeks.

          -  Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of
             Baseline Visit.

          -  Initiation of physical therapy or muscle conditioning program within 2 months prior to
             study entry.

          -  Concurrent use of the following medications and dietary supplements.

               -  Chronic therapy with tetracycline or tetracycline derivatives.

               -  Other new complementary or alternative regimens for the treatment of
                  osteoarthritis, including, but not limited to, acupuncture, topical creams, oral
                  agents, and magnets.