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
18 Years
N/A
Female
Breast Cancer, Joint Pain
Trial Information
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
Post-menopausal women currently on AIT for breast cancer treatment who self-report
musculoskeletal side effects related to AIT to their physicians.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Nathalie Johnson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Legacy Health System
Authority:
United States: Institutional Review Board
Study ID:
Blue Citrus BC-AIT-001
NCT ID:
NCT00702858
Start Date:
April 2008
Completion Date:
June 2011
Related Keywords:
- Breast Cancer
- Joint Pain
- Breast Cancer
- Joint Pain
- Aromatase Inhibitors
- Arthralgia
- Breast Neoplasms
Name | Location |
|---|
