Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients

Vitamin D and breast cancer

This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.

2022-11-01

2024-09-01

2024-10-01

Recruiting

Early phase I

40

Inclusion Criteria: * Newly diagnosed breast cancer patients. * Postmenopausal hormone receptor positive. * Patients receiving letrozole for more than two months * Gender: Female. * Age: ≥ 50 years old. Exclusion Criteria: * Patients with bone metastasis. * History of renal stones. * Serum calcium \>11mg/L. * Patients with renal insufficiency. * Patients taking steroid hormone replacement therapy. * Second Malignancy.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-12-01