Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
Summary
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.
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
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 Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Conditions
Breast Cancer
Intervention
Blue Citrus, Placebo
Location
Legacy Health System
Portland
Oregon
United States
97210
Status
Recruiting
Source
Legacy Health System
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00702858
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
Breast Neoplasms
Tumors or cancer of the human BREAST.
Brca1 Protein
The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)
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