Skip to main content
OpenTrials
Completed

NCT Number: NCT00702858

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Arthralgia Breast Diseases Breast Neoplasms Joint Diseases Joint Pain Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue Citrus

Drug

Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months

Placebo

Drug

Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

Primary outcomes

  1. Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo

    Time frame: 6 months

Secondary outcomes

  1. Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo

    Time frame: 6 months

  2. Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Legacy Health System

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2008
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.