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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: June 15, 2017
Last verified: June 2017
  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 Joint Pain Drug: Chondroitin Drug: Glucosamine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 Dawn L. Hershman, Columbia University:

Primary Outcome Measures:
  • Prevalence of reduced knee and/or joint pain and/or stiffness [ Time Frame: 24 weeks ]
    Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which provides a combined assessment of changes in pain, function, and the patient's global assessment of disease status.


Enrollment: 53
Study Start Date: October 2008
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chondroitin and glucosamine
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Drug: Chondroitin
400mg chondroitin TID for twenty-four weeks
Other Name: Chondroitin sulfate
Drug: Glucosamine
500mg glucosamine TID for twenty-four weeks
Other Name: Glucosamine sulfate

Detailed Description:
Due to early detection and improved treatments, women with breast cancer are living longer. The increase in breast cancer survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences. However, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness. Musculoskeletal pain, which occurs in up to 50% of patients treated with AIs, often does not respond to conventional pain medications, may lead to noncompliance, may cause major disability, and may interfere with quality of life. Many women are unable to tolerate these life-saving drugs because of severe joint pain, therefore, safe and effective treatments that alleviate these symptoms are needed.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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 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.
  • 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.
  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

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: June 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dawn L. Hershman, Columbia University:
breast cancer
aromatase inhibitor
supportive care

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017