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| Sponsor: | Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00691678 |
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 |
Dietary Supplement: Glucosamine Chondroitin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients |
| Estimated Enrollment: | 53 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
Glucosamine Chondroitin
|
Dietary Supplement: Glucosamine Chondroitin
Glucosamine [500mg three times daily (TID) x 24 weeks] plus chondroitin (400mg TID x 24 weeks)
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including:
Contacts and Locations| Contact: Dawn L Hershman, MD | 212-305-1945 | dlh23@columbia.edu |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Dawn L Hershman, MD | |
| Principal Investigator: | Dawn Hershman, MD | Columbia University |
More Information
| Responsible Party: | Columbia University ( Dawn Hershman ) |
| Study ID Numbers: | IRB-AAAC8748 |
| Study First Received: | June 3, 2008 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00691678 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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breast cancer aromatase inhibitor supportive care |
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Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Breast Neoplasms |
Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions Breast Diseases |