Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
NCT ID: NCT00702858
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2008-04-30
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
NCT02246621
Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors
NCT00738998
Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study
NCT00653718
Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients
NCT01814397
Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain
NCT01028352
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Blue Citrus either months 1-3 or 4-6
Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
2
Placebo
Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient complaints of musculoskeletal symptoms
3. Currently taking AIT for ER positive postmenopausal breast cancer
Exclusion Criteria
2. Presence of bone metastasis
3. Unable to complete VAS Pain Scale
4. Unable to comply/complete SF 12 Quality of Life survey
5. Plan to discontinue AIT in less then six months
6. Unable to complete ADL scale
7. Have diagnosis of fibromyalgia
8. Have diagnosis of rheumatoid arthritis
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Legacy Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nathalie Johnson
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nathalie Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Legacy Health System
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Blue Citrus BC-AIT-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.