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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Joint Pain
• Intervention / Treatment: Drug: Blue Citrus; Drug: Placebo

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; Placebo	Drug: Placebo; Five Placebo capsules three times a day to equal 15 capsules per day for 3 months
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Legacy Health System

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: June 19, 2008
• First Posted (ESTIMATE): June 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Breast Cancer; Aromatase Inhibitors; Joint Pain
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Joint Diseases; Musculoskeletal Diseases; Breast Neoplasms; Arthralgia
• Other Study ID Numbers: Blue Citrus BC-AIT-001