High Dose Vitamin D vs Standard Dose Vitamin D Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/21/2019 |
| Start Date: | December 2013 |
| End Date: | December 2019 |
A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors
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).
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).
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.
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.
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.
We found this trial at
2
sites
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-1929
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4960 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Foluso Ademuyiwa, MD
Phone: 314-362-0263
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