High Dose Vitamin D vs Standard Dose Vitamin D Study
Keywords
Abstract
Description
Treatments with anti-estrogen agents for hormone receptor positive breast cancer is the most efficacious of systemic therapies, with aromatase inhibitors (AI's) being considered the most active anti-estrogen therapy in early stage breast cancer. But, use of these treatments has been shown to cause musculoskeletal (joint/muscle) side effects that sometimes cause patients to discontinue the use of them. Also, Vitamin D deficiency is a well know cause of a wide array of musculoskeletal issues. There is evidence that Vitamin D supplementation may help prevent arthralgia while on AI's. Therefore, the investigators want to see if giving a higher dose of Vitamin D could decrease the incidence of AIA as compared to a standard dose of Vitamin D. The investigators believe that this could possibly result in patients continued treatment with AI therapy for hormone receptor positive breast cancer.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 11/06/2013 |
| Estimated Enrollment Submitted: | 11/12/2013 |
| First Posted: | 11/19/2013 |
| Last Update Submitted: | 07/08/2020 |
| Last Update Posted: | 07/23/2020 |
| Date of first submitted results: | 01/30/2019 |
| Date of first submitted QC results: | 02/27/2019 |
| Date of first posted results: | 03/18/2019 |
| Actual Study Start Date: | 11/30/2013 |
| Estimated Primary Completion Date: | 07/20/2018 |
| Estimated Study Completion Date: | 12/09/2018 |
Condition or disease
Intervention/treatment
Drug: 800 IU Vitamin D Supplement
Drug: High Dose Vitamin D ARM
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: High Dose Vitamin D ARM 50,000 IU Vitamin D supplement | Drug: High Dose Vitamin D ARM High Dose |
| Active Comparator: 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement | Drug: 800 IU Vitamin D Supplement Standard Dose |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy [12 weeks]
Secondary Outcome Measures
1. Compliance With Anti-Cancer Treatment [52 Weeks]
2. Association Between Vitamin D Levels Changes and Treatment. [12 weeks]
Other Outcome Measures
1. Grip Strength [52 weeks]
