Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702858
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Joint Pain Drug: Blue Citrus Drug: Placebo Not Applicable

Detailed Description:
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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 Start Date : April 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Blue Citrus either months 1-3 or 4-6
Drug: Blue Citrus
Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months
Placebo Comparator: 2
Drug: Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

Primary Outcome Measures :
  1. Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo [ Time Frame: 6 months ]
  2. Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00702858

Sponsors and Collaborators
Legacy Health System
Principal Investigator: Nathalie Johnson, MD Legacy Health System

Responsible Party: Nathalie Johnson, Principal Investigator, Legacy Health System Identifier: NCT00702858     History of Changes
Other Study ID Numbers: Blue Citrus BC-AIT-001
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Nathalie Johnson, Legacy Health System:
Breast Cancer
Joint Pain
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs