Breast Neoplasms
Conditions
Brief summary
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Detailed description
This is a pilot, double-blind, randomized, placebo-controlled study with the following aims: * To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml). * To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic. * To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms. * To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
Interventions
DIETARY_SUPPLEMENTVitamin D
DIETARY_SUPPLEMENTCalcium carbonate
OTHERPlacebo
Sponsors
AstraZeneca
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS) * Postmenopausal status * Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry * Completed systemic chemotherapy and radiation treatments when indicated * Serum Calcium ≤ 10.3 mg/dL * Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group * 24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine) * A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy
Exclusion criteria
* Known metastatic disease * History of kidney stones * History of active primary hyperparathyroidism * History of Paget's disease of the bone * History of severe arthritis, rheumatoid arthritis, or severe neuropathy * Normal 25 OH Vitamin D level (≥ 30 ng/ml) * Medical or psychiatric condition which may preclude protocol compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml). | 6 months for randomized phase, 12 months for open-label phase |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic. | 6 months for randomized phase, 12 months for open-label phase |
| To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms. | 6 months |
| To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms. | 6 months |
Countries
United States
Outcome results
None listed