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This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).
Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Blue Citrus either months 1-3 or 4-6 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue Citrus | Drug | Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo | 6 months | |
| Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Johnson, MD | Legacy Health System | Principal Investigator |
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| Placebo |
| Drug |
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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