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

August 27, 2013 updated by: Nathalie Johnson, Legacy Health System

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
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
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Blue Citrus BC-AIT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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