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Sponsored by: |
Legacy Health System |
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Information provided by: | Legacy Health System |
ClinicalTrials.gov Identifier: | NCT00702858 |
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.
Condition | Intervention |
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Breast Cancer Joint Pain |
Drug: Blue Citrus Other: Placebo |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Blue Citrus either months 1-3 or 4-6
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Drug: Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
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2: Placebo Comparator
Placebo
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Other: Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
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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.
Inclusion Criteria
Exclusion Criteria
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aaron W, BA, BS | 503-413-8199 | |
Contact: Crystal H, BS | 503-413-8199 |
United States, Oregon | |
Legacy Health System | Recruiting |
Portland, Oregon, United States, 97210 |
Principal Investigator: | Nathalie Johnson, MD | Legacy Health System |
Responsible Party: | Legacy Health Systems ( Nathalie Johnson, MD ) |
Study ID Numbers: | Blue Citrus BC-AIT-001 |
Study First Received: | June 19, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00702858 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Joint Pain Aromatase Inhibitors |
Signs and Symptoms Estrogens Skin Diseases Musculoskeletal Diseases Joint Diseases Breast Neoplasms |
Pain Aromatase Inhibitors Arthralgia Menopause Breast Diseases |
Skin Diseases Molecular Mechanisms of Pharmacological Action Joint Diseases Breast Neoplasms Pain Enzyme Inhibitors Pharmacologic Actions |
Signs and Symptoms Neoplasms Neoplasms by Site Musculoskeletal Diseases Aromatase Inhibitors Arthralgia Breast Diseases |