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:
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
ClinicalTrials.gov Identifier:
NCT00702858
First received: June 19, 2008
Last updated: August 27, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Legacy Health System:

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

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

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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702858

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

No publications provided

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
Study First Received: June 19, 2008
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014