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Trial Title:
Vitamin D and Calcium Supplementation in Breast Cancer
NCT ID:
NCT05523609
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Vitamin D
Cholecalciferol
Letrozole
Calcium
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Letrozole 2.5mg
Description:
20 patients will receive Letrozole only for 12 weeks
Arm group label:
Control Group
Intervention type:
Drug
Intervention name:
Letrozole + vitamin D3 and calcium
Description:
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12
weeks.
Arm group label:
VitD/Ca group
Summary:
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.
Detailed description:
Background: Vitamin D deficiency (< 10 ng/mL) and insufficiency (10-30 ng/mL) may
contribute to musculoskeletal symptoms observed in patients taking letrozole. This study
was undertaken to assess the vitamin D status in breast cancer patients who received
letrozole for > 6 months and to evaluate the effects of vitamin D3 and calcium
supplementation on them.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tanta Cancer Center
Address:
City:
Tanta
Zip:
GHR
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mai A Hamouda, Pharm D
Phone:
01061412257
Phone ext:
0
Email:
pg_55464@pharm.tanta.edu.eg
Start date:
November 1, 2022
Completion date:
October 2024
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523609
