A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
18 Years
N/A
Female
Breast Cancer
Trial Information
A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D)
and various quality of life measures in women being treated with letrozole as standard care
for early stage breast cancer.
Inclusion Criteria:
- Post-menopausal women newly diagnosed with early stage breast cancer, who would be
treated with an aromatase inhibitor
- Serum 25OHD levels < 40 ng/ml
Exclusion Criteria:
- Severe or debilitating musculoskeletal pain
- Known metastatic disease
- History of renal stones
- History of hypercalcemia or hyperthyroidism
- Currently receiving adjuvant or neoadjuvant chemotherapy
- Currently receiving other investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Assessments of musculoskeletal symptoms: Health Assessment Questionnaire II (HAQ II), Joint Pain Score, Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI)
Outcome Time Frame:
24 weeks
Safety Issue:
Yes
Principal Investigator
Qamar J Khan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Kansas
Authority:
United States: Food and Drug Administration
Study ID:
11548
NCT ID:
NCT00867217
Start Date:
March 2009
Completion Date:
September 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Cancer Centers of Kansas, P.A. | Wichita, Kansas 67214 |
