Back to resultsTrial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
Primary Purpose
Breast Cancer, Joint Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blue Citrus
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Joint Pain, Aromatase Inhibitors
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Blue Citrus either months 1-3 or 4-6
Placebo
Outcomes
Primary Outcome Measures
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
Secondary Outcome Measures
Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo
Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00702858
Brief Title
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Joint Pain
Keywords
Breast Cancer, Joint Pain, Aromatase Inhibitors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Blue Citrus either months 1-3 or 4-6
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Blue Citrus
Intervention Description
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
Primary Outcome Measure Information:
Title
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo
Time Frame
6 months
Title
Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Johnson, MD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
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