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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702858
First Posted: June 20, 2008
Last Update Posted: August 28, 2013
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.
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
  Purpose

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 Intervention
Breast Cancer Joint Pain Drug: Blue Citrus Drug: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nathalie Johnson, Legacy Health System:

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

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

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00702858


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

Responsible Party: Nathalie Johnson, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT00702858     History of Changes
Other Study ID Numbers: Blue Citrus BC-AIT-001
First Submitted: June 19, 2008
First Posted: June 20, 2008
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
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
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