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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
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
More Information
| Responsible Party: | Dawn Hershman, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00691678 History of Changes |
| Other Study ID Numbers: | AAAC8748 |
| Study First Received: | June 3, 2008 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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breast cancer aromatase inhibitor supportive care |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |