Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Apr 2008
Typical duration for not_applicable breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 28, 2013
August 1, 2013
3.2 years
June 19, 2008
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
6 months
Secondary Outcomes (2)
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
Study Arms (2)
1
ACTIVE COMPARATORBlue Citrus either months 1-3 or 4-6
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Johnson, MD
Legacy Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 28, 2013
Record last verified: 2013-08