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Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer

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Abstract

Purpose

Many women with hormone receptor-positive breast cancer discontinue effective aromatase inhibitor (AI) treatment due to joint symptoms.

Methods

We conducted a single-arm, open-label, phase II study evaluating glucosamine-sulfate (1,500 mg/day) + chondroitin-sulfate (1,200 mg/day) for 24 weeks to treat joint pain/stiffness in postmenopausal women with early stage breast cancer who developed moderate-to-severe joint pain after initiating AIs. The primary endpoint was improvement in pain/stiffness at week 24 assessed by the Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria. Secondary endpoints assessed changes in pain, stiffness, and function using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index for hips/knees and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) for hands/wrists. The Brief Pain Inventory (BPI) assessed pain interference, severity, and worst pain.

Results

Of 53 patients enrolled, 39 were evaluable at week 24. From baseline to week 24, 46 % of patients improved according to OMERACT-OARSI criteria. At week 24, there were improvements (all P < 0.05) in pain and function as assessed by WOMAC and M-SACRAH, and in pain interference, severity, and worst pain as assessed by BPI. Estradiol levels did not change from baseline. The most commonly reported side effects were headache (28 %), dyspepsia (15 %), and nausea (17 %).

Conclusions

In this single-arm study, 24 weeks of glucosamine/chondroitin resulted in moderate improvements in AI-induced arthralgias, with minimal side effects, and no changes in estradiol levels. These results suggest a need to evaluate efficacy in a placebo-controlled trial.

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Acknowledgments

We thank the women who participated in the study. This research was supported by AstraZeneca (D.L.H.), the Breast Cancer Research Foundation (D.L.H.), the National Cancer Institute (K23CA141052 to H.G.), and Grant Number UL1 RR024156 from the National Center for Research Resources, a component of the National Institutes of Health and National Institutes of Health Roadmap for Medical Research. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the funding agencies.

Ethical standards

The CUMC institutional review board approved the study, and all participants provided written informed consent in English or Spanish.

Conflict of interest

The authors declare that they have no conflict of interest. We have full control of all primary data, and we agree to allow the journal to review the data if requested.

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Authors and Affiliations

  1. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA

    Heather Greenlee, Katherine D. Crew, Beverly Insel & Dawn L Hershman

  2. Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA

    Heather Greenlee, Katherine D. Crew, Theresa Shao, Kevin Kalinsky, Matthew Maurer & Dawn L Hershman

  3. Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA

    Heather Greenlee, Katherine D. Crew, Theresa Shao, Grace Kranwinkel, Kevin Kalinsky, Matthew Maurer, Lois Brafman, Wei Yann Tsai & Dawn L Hershman

  4. Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA

    Wei Yann Tsai

  5. Columbia University, 161 Fort Washington Avenue, Room 1068, New York, NY, 10032, USA

    Dawn L Hershman

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  1. Heather Greenlee
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  2. Katherine D. Crew
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  10. Dawn L Hershman
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Correspondence to Dawn L Hershman.

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Greenlee, H., Crew, K.D., Shao, T. et al. Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer. Support Care Cancer 21, 1077–1087 (2013). https://doi.org/10.1007/s00520-012-1628-z

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