High Dose Vitamin D vs Standard Dose Vitamin D Study

Mothaffar Rimawi

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: 50,000 IU Vitamin D supplement

Drug: 800 IU Vitamin D Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT01988090

H-33261

Details and patient eligibility

About

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).

Full 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.

Enrollment

93 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.