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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702858

Enrollment

Registered

2008-06-20

Start date

2008-04-30

Completion date

2011-06-30

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Joint Pain

Keywords

Breast Cancer, Joint Pain, Aromatase Inhibitors

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.

Interventions

DRUGBlue Citrus

Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months

DRUGPlacebo

Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level \>40 2. Patient complaints of musculoskeletal symptoms 3. Currently taking AIT for ER positive postmenopausal breast cancer

Exclusion criteria

1. Previously taken Blue Citrus 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

Design outcomes

Primary

Measure	Time frame
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo	6 months

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026