Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2022-11-01
2024-10-31
Brief Summary
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Detailed Description
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Methods: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
20 patients will receive Letrozole only for 12 weeks.
Letrozole 2.5mg
20 patients will receive Letrozole only for 12 weeks
VitD/Ca group
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
Letrozole + vitamin D3 and calcium
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.
Interventions
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Letrozole 2.5mg
20 patients will receive Letrozole only for 12 weeks
Letrozole + vitamin D3 and calcium
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal hormone receptor positive.
* Patients receiving letrozole for more than two months
* Gender: Female.
* Age: ≥ 50 years old.
Exclusion Criteria
* History of renal stones.
* Serum calcium \>11mg/L.
* Patients with renal insufficiency.
* Patients taking steroid hormone replacement therapy.
* Second Malignancy.
50 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mai Abo Elyazeed Hassan Hamouda
Clinical Pharmacist
Principal Investigators
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Sahar K Hegazy, Professor
Role: STUDY_DIRECTOR
Head of clinical Pharmacy Department
Locations
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Tanta Cancer Center
Tanta, El-Gharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mai A Hamouda, Pharm D
Role: primary
Other Identifiers
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Vitamin D and breast cancer
Identifier Type: -
Identifier Source: org_study_id