Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Official Title
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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

Conditions
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Breast Cancer, Joint Pain

Intervention / Treatment
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* Drug: Blue Citrus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post Menopausal - evidenced by no menses for the past 6 months or FSH level >40 Patient complaints of musculoskeletal symptoms Currently taking AIT for ER positive postmenopausal breast cancer Exclusion Criteria: Previously taken Blue Citrus Presence of bone metastasis Unable to complete VAS Pain Scale Unable to comply/complete SF 12 Quality of Life survey Plan to discontinue AIT in less then six months Unable to complete ADL scale Have diagnosis of fibromyalgia Have diagnosis of rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Blue Citrus either months 1-3 or 4-6 | Drug: Blue Citrus<br>* Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Five Placebo capsules three times a day to equal 15 capsules per day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Joint Pain, Aromatase Inhibitors