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Project Title Vitamin D3 Effects on Musculoskeletal Symptoms with Use of Aromatase Inhibitors (D3AI)

Researcher Alice Shapiro, PhD, RD, LN and the Oncology Research Team at Park Nicollet Health Services and the University of Minnesota

Study Summary The study compares two doses of vitamin D3: the current recommended daily allowance (600 IU/day) and the known upper safe level (4,000 IU/day). The main goals of this study are to determine whether higher daily doses of vitamin D3 reduce musculoskeletal pain better than the standard daily dose; determine whether higher doses of vitamin D3 makes it easier for women who have musculoskeletal pain to stay on an aromatase inhibitor for a longer period of time; and compare changes in estrogen levels, bone density and body composition, between women assigned to the two different doses of vitamin D3.

Who Can Participate? You can sign up for the Vitamin D3 Effects on Musculoskeletal Symptoms with Use of Aromatase Inhibitors (D3AI) study if you meet all of these main criteria:

• You are a woman over the age of 18.
• You are post-menopausal.
• You were diagnosed with breast cancer (Stage I, II or IIIa).
• Your breast cancer was hormone-receptor positive [either estrogen positive (ER+), progesterone positive (PR+) or both].
• You do not have Stage IV, metastatic breast cancer
• You have completed initial treatment for your breast cancer (surgery and/or chemotherapy and/or tamoxifen)
• You were prescribed and have been taking Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane) for at least one month and are scheduled to continue taking them for at least 7 more months.
• This is the first time you have been prescribed an aromatase inhibitor for breast cancer
• You are experiencing musculoskeletal pain and/or weakness.
• You are willing to take ONLY study-supplied vitamin D and calcium. Other supplements are OK but they must not contain additional vitamin D or calcium
• You live near or are willing to travel to the Frauenshuh Cancer Center at Park Nicollet Health Services in St. Louis Park, Minnesota (on the Methodist Hospital Campus).

After you RSVP, the research team will contact you to ask additional questions to be sure that the study is a good fit for you.

What Does Participation Involve? If you sign up for this study, you will be contacted by the research team to confirm that you meet the main requirements which are explained in more detail below. If you choose to participate in the study, you will go to the study site in St. Louis Park and be asked to have a pre-study visit to verify that you can be in the study. These screening procedures may occur at one or more visits:

• Your medical background information and a review of what medications you are taking will be collected
• You will complete a questionnaire
• You will have a DEXA scan – a scan of your spine, hip, and legs that measures the density of your bones and also measures your body’s composition of protein, bone and fat tissue

If you are eligible to participate and choose to do so, you will be asked to discontinue taking any of your own vitamins that contain calcium or vitamin D, and start taking 600 IU of vitamin D3 plus 500 mg of calcium per day in the mornings for 30 days. This is called a “wash-out” period and ensures that everyone is taking the same amount of vitamin D3 and calcium for 30 days prior to taking different doses. After this, you will be asked to go back to the study site for your baseline visit. At that visit, you will be randomly assigned (like choosing by the flip of a coin) to one of two groups:

• Investigational group: 4000 IU of vitamin D3 plus 500 mg of calcium daily for 6 months
• Usual care group: 600 IU of vitamin D3 plus 500 mg of calcium daily for 6 months

You will be asked to go to the study site for the baseline visit (30 days after starting the study) and then again at 1 ½, 3 and 6 months (total of 5 study visits over 7 months). At these visits, you may be asked to have the following tests and procedures:

• Review of your current medication
• Vital signs and physical examination
• Blood samples (approximately 1-3 tablespoons will be collected)
• Measurement of your hand grip strength
• Complete questionnaires
• Review of your Aromatase Inhibitor Adherence and Pain Medication diaries
• DEXA scan (6 month visit only)

The research team will explain all study activities in detail.

Where? Frauenshuh Cancer Center at Park Nicollet Health Services in St. Louis Park, Minnesota (located on the Methodist Hospital campus).