Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy|
- Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Blue Citrus either months 1-3 or 4-6
Drug: Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
Placebo Comparator: 2
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.