Breast Cancer | High Dose Vitamin D vs Standard Dose Vitamin D Study
Breast Cancer research study
What is the primary objective of this study?
This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).
Who is eligible to participate?
Inclusion Criteria: - All participants must be female and at least 21 years of age - Signed informed consent - Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR). - Post-menopausal - Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks - Bisphosphonates are allowed at the treating investigator¡¦s discretion - Performance status (WHO/ECOG scale) 0-2. Exclusion Criteria: - History of kidney stones - Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters - History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion - Baseline Vitamin D level greater than 50 ng/mL - Inability or unwillingness to comply with, or follow study procedures. - Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat - Malabsorption syndrome, such as Crohn's disease Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:800 IU Vitamin D SupplementStandard Dose
Drug:50,000 IU Vitamin D supplementHigh Dose
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
High Dose Vitamin D ARM50,000 IU Vitamin D supplement
800 IU Vitamin D Supplement800 IU Vitamin D Supplement
Active, not recruiting
Start Date: December 2013
Completed Date: December 2019
Phase: Phase 2
Primary Outcome: Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
Secondary Outcome: Compliance With Anti-Cancer Treatment
Study sponsors, principal investigator, and references
Principal Investigator: Mothaffar Rimawi, MD
Lead Sponsor: Mothaffar Rimawi