Please select the eligibility criteria that correspond to the clinical trial below.
Title: Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
Brief Summary: The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown.

In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.


Options:
A: Inclusion Criteria:

* Postmenopausal status
* Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
* AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
* Vitamin D deficiency (\<30ng/ml)
* Caucasian

Exclusion Criteria:

* Hormone replacement therapy last 6 months
* Current use or in the last 12 months of bisphosphonates
* Tamoxifen use in last 6 months
* History of kidney stones
* History of hypercalcemia/hypercalciuria or hyperthyroidism
* Paget's disease of the bone
* Current use of Digitalis/digoxin or thiazide diuretics
* Current use of vitamin D (or multivitamin) supplementation should be stopped
B: Inclusion Criteria:

* Age \>18 years
* Diagnosis of gynecologic (ovarian; cervical; uterine; primary peritoneal), lung (non-small cell; small cell), gastrointestinal (colorectal, rectal, gastric, esophageal, GI neuroendocrine, small intestine malignancy, pancreatic, hepatocellular), breast, bladder cancer or prostate malignancy
* Receiving primary medical oncology care at MSKCC medical oncology outpatient clinics
* Receiving cytotoxic chemotherapy not on a clinical trial (or a new hormonal therapy in the case of prostate cancer patients only), with treatment expected to continue for at least four weeks from the time of enrollment
* Signed informed consent and Research Authorization

Exclusion Criteria:

* ECOG performance status greater than 2
* Unable to read and comprehend English language text
C: DISEASE CHARACTERISTICS:

* Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal
* ECOG performance status 0-1
* Able to understand and respond to questions in English
* No condition that would impair the ability to provide informed consent
* No other non-breast cancer condition

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 9 prior doses of AI
D: Inclusion Criteria:

* Age ≥ 18 years
* Women with a history of stage I-IIIa invasive breast cancer
* History of hormone-receptor positive cancer (either ER + or PR + or both)
* Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
* Are experiencing AIMSS

Exclusion Criteria:

* Unable to read or understand English
* History of psychiatric disability affecting informed consent or compliance with drug intake
* Malabsorption syndrome or inability to take oral medication
* Has less than 7 months of AI therapy remaining

Answer: A