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

Sponsored by:	Legacy Health System
Information provided by:	Legacy Health System
ClinicalTrials.gov Identifier:	NCT00702858

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 Other: Placebo

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator Placebo	Other: 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.

Inclusion Criteria

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

Exclusion Criteria

Previously taken Blue Citrus
Presence of bone metastasis
Unable to complete VAS Pain Scale
Unable to comply/complete SF 12 Quality of Life survey
Plan to discontinue AIT in less then six months
Unable to complete ADL scale
Have diagnosis of fibromyalgia
Have diagnosis of rheumatoid arthritis

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previously taken Blue Citrus
Presence of bone metastasis
Unable to complete VAS Pain Scale
Unable to comply/complete SF 12 Quality of Life survey
Plan to discontinue AIT in less then six months
Unable to complete ADL scale
Have diagnosis of fibromyalgia
Have diagnosis of rheumatoid arthritis

Contacts and Locations

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

Contacts

Contact: Aaron W, BA, BS	503-413-8199
Contact: Crystal H, BS	503-413-8199

Locations

United States, Oregon
Legacy Health System	Recruiting
Portland, Oregon, United States, 97210

Sponsors and Collaborators

Legacy Health System

Investigators

Principal Investigator:

Nathalie Johnson, MD

Legacy Health System

More Information

No publications provided

Responsible Party:	Legacy Health Systems ( Nathalie Johnson, MD )
Study ID Numbers:	Blue Citrus BC-AIT-001
Study First Received:	June 19, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00702858 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Legacy Health System:

Breast Cancer
Joint Pain
Aromatase Inhibitors

Study placed in the following topic categories:

Signs and Symptoms
Estrogens
Skin Diseases
Musculoskeletal Diseases
Joint Diseases
Breast Neoplasms

Pain
Aromatase Inhibitors
Arthralgia
Menopause
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Joint Diseases
Breast Neoplasms
Pain
Enzyme Inhibitors
Pharmacologic Actions

Signs and Symptoms
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Aromatase Inhibitors
Arthralgia
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009